Clinical Insights: August 6th, 2025

Clinical Insights: October 22nd, 2025

Clinical Insights: September 10th, 2025

Welcome to Pillr Health’s Clinical Insights, designed to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy marketplace.

New Drug/Vaccine Approval

Wayrilz™ (rilzabrutinib) Tablets – New Drug Approval – August 28, 2025 – The US Food and Drug Administration (FDA) has approved Wayrilz™ (rilzabrutinib) for adults with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. The approval was based on the pivotal LUNA 3 phase 3 study, in which Wayrilz™ met the primary and secondary endpoints, showing a positive impact on sustained platelet counts and other ITP symptoms. <Read More>

Dawnzera™ (donidalorsen) Injection – New Drug Approval – August 21, 2025 – Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced that the U.S. Food and Drug Administration (FDA) has approved Dawnzera™ (donidalorsen) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older. Dawnzera™ is the first and only RNA-targeted medicine approved for HAE, designed to target plasma prekallikrein (PKK), a key protein that activates inflammatory mediators associated with acute attacks of HAE. Dawnzera™ 80mg is self-administered via subcutaneous autoinjector once every four (Q4W) or eight weeks (Q8W). <Read More> 

Tonmya™ (cyclobenzaprine hydrochloride) - formerly TNX-102 SL – New Drug Approval – August 15, 2025 – Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully-integrated biotechnology company, announced that the U.S. Food and Drug Administration (FDA) approved Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults. Tonmya™ is a first-in-class, non-opioid, once-daily bedtime analgesic with a unique sublingual (under the tongue) formulation that is designed for rapid absorption into the bloodstream. Tonmya™ is the first new FDA-approved therapy for the treatment of fibromyalgia in over 15 years. <Read More>

Papzimeos™ (zopapogene imadenovec-drba) Injection – New Drug Approval – August 14, 2025 – Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the advancement of innovative precision medicines to improve the lives of patients, announced that the US Food and Drug Administration (FDA) has approved Papzimeos™ (zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis (RRP). Papzimeos™ is the first and only FDA-approved therapy for the treatment of adults with RRP. Precigen completed submission of the rolling Biologics License Application (BLA) in December 2024 under an accelerated approval pathway; however, the FDA has granted Papzimeos™ full approval, which does not require a confirmatory clinical trial. Papzimeos™ is a non-replicating adenoviral vector-based immunotherapy designed to express a fusion antigen comprising selected regions of human papillomavirus (HPV) types 6 and 11 proteins—the root cause of RRP. Papzimeos™ is delivered via four subcutaneous injections over a 12-week interval. <Read More>

Brinsupri™ (brensocatib) Tablets – New Drug Approval – August 12, 2025 – Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, announced that the U.S. Food and Drug Administration (FDA) has approved first-in-class Brinsupri™ (brensocatib 10 mg and 25 mg tablets), an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (NCFB) in adults and children 12 years and older. Brinsupri™ is the first and only FDA-approved treatment for NCFB, giving hundreds of thousands of patients and clinicians across the U.S. an option to manage this chronic and progressive disease that can lead to permanent lung damage and lung function decline. <Read More> 

Hernexeos® (zongertinib) Tablets – New Drug Approval – August 8, 2025 – Boehringer Ingelheim’s Hernexeos® (zongertinib tablets) has been approved by the U.S. Food and Drug Administration (FDA). The kinase inhibitor is indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy. <Read More>  

KETARx™ (ketamine hydrochloride) Injection – New Drug Approval – August 7, 2025 – PharmaTher Holdings Ltd. (the "Company" or "PharmaTher") (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company focused on unlocking the pharmaceutical potential of ketamine, announced the advancement of its ketamine transdermal patch as a next-generation, non-opioid pain relief solution, building on the recent FDA approval of its IV ketamine product (KETARx™). <Read More> 

Modeyso™ (dordaviprone) Capsules – New Drug Approval – August 6, 2025 – Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Modeyso™ (dordaviprone) for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the Phase 3 ACTION confirmatory trial. <Read More>

New Label Expansions

Leqembi® (lecanemab-irmb) Injection – New Label Expansion – August 29, 2025 – Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for once weekly lecanemab-irmb subcutaneous injection (U.S. brand name: Leqembi® Iqlik™, pronounced "I Click") for maintenance dosing. Leqembi® Iqlik™ is a subcutaneous autoinjector (SC-AI) developed by Eisai, containing 360 mg/1.8 mL (200 mg/mL) that can be administered in approximately 15 seconds. <Read More> 

Comirnaty® (COVID-19 Vaccine, mRNA) Injection – New Label Expansion – August 27, 2025 – Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) announced the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the companies’ LP.8.1-adapted monovalent COVID-19 vaccine (Comirnaty® LP.8.1; COVID-19 Vaccine, mRNA) for use in adults ages 65 years and older, as well as in individuals ages 5 through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. <Read More>

Filspari® (sparsentan) Tablets – New Label Expansion – August 27, 2025 – Travere Therapeutics, Inc., (Nasdaq: TVTX) announced that the U.S. Food and Drug Administration (FDA) has approved updated Risk Evaluation and Mitigation Strategy (REMS) labeling for Filspari® (sparsentan), the only Dual Endothelin Angiotensin Receptor Antagonist for the treatment of IgA nephropathy (IgAN). <Read More> 

mNEXSPIKE® (COVID-19 Vaccine, mRNA) Injection – New Label Expansion – August 27, 2025 – Moderna, Inc. (NASDAQ:MRNA) announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Applications (sBLA) for the 2025-2026 formulas for Spikevax® and mNEXSPIKE®, targeting the LP.8.1 variant of SARS-CoV-2 to help prevent COVID-19. <Read More> 

Nuvaxovid™ (COVID-19 Vaccine, Adjuvanted) Injectable Suspension – New Label Expansion – August 27, 2025 – Novavax, Inc. (Nasdaq: NVAX) announced that the U.S. Food and Drug Administration has approved the Nuvaxovid™ 2025-2026 Formula for the prevention of COVID-19 in individuals 65 years of age and older, or 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. <Read More> 

Repatha® (evolocumab) Injection – New Label Expansion – August 21, 2025 – Amgen (NASDAQ:AMGN) announced that the U.S. Food and Drug Administration (FDA) has broadened the approved use of Repatha® (evolocumab) to include adults at increased risk for major adverse cardiovascular events (MACE) due to uncontrolled low-density lipoprotein cholesterol (LDL-C), commonly known as 'bad cholesterol.' The update removes a prior requirement for a patient to have been diagnosed with cardiovascular (CV) disease. <Read More> 

Wegovy® (semaglutide) Injection – New Label Expansion – August 15, 2025 – The U.S. Food and Drug Administration has approved Wegovy® (semaglutide) injection to treat metabolic-associated steatohepatitis (MASH) in adults with moderate-to-advanced fibrosis (excessive scar tissue in the liver). MASH, also known as nonalcoholic steatohepatitis, is a serious liver disease. Wegovy®, which was first approved in 2017, is also approved for obesity or overweight and to reduce cardiovascular events, such as heart attacks, in individuals at high risk of these events. Approximately 6% of U.S. adults (14.9 million people) have MASH, and its prevalence is expanding. <Read More> 

Ajovy® (fremanezumab-vfrm) Injection – New Label Expansion – August 5, 2025 – Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced that the U.S. Food and Drug Administration (FDA) has approved Ajovy® for the preventive treatment of episodic migraine in children and adolescent patients aged 6-17 years who weigh 45 kilograms (99 pounds) or more. <Read More> 

New Drug Shortage

September 8, 2025

September 4, 2025

August 29, 2025

August 27, 2025

August 25, 2025

Updated Drug Shortage

September 5, 2025

September 4, 2025

September 3, 2025

September 2, 2025

August 29, 2025

New Drug Recall and Safety Alerts

Cyclobenzaprine Hydrochloride Tablets USP 10 mg by Unichem Pharmaceuticals (USA) Inc. – New Voluntary Recall – August 27, 2025 – Unichem Pharmaceuticals (USA), Inc. is voluntarily recalling one (1) lot of cyclobenzaprine Hydrochloride Tablets USP 10 mg, to the consumer level. The Cyclobenzaprine 10mg (90ct) label was inadvertently placed on a bottle containing Meloxicam 7.5 mg tablets. <Read More> 

Lactated Ringer’s Injection USP 1000 mL and 0.9% Sodium Chloride Injection USP 1000 mL by B. Braun Medical – New Voluntary Recall  – August 19, 2025 - B. Braun Medical Inc. (B. Braun) is voluntarily recalling two lots of Lactated Ringers Injection USP 1000 mL, and 0.9% Sodium Chloride Injection USP 1000 mL to the hospital level due to the presence of particulate matter inside the container. B. Braun has identified through complaints the potential for the product to contain particulate matter in solution. To date there have been no reports of serious injury, death or other adverse events associated with this issue. <Read More> 

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

Walgreens Shakeup Sparks Patient Fear as Pharmacies Face More Closures After 295 Shutters – September 8, 2025 – A few months after a definitive agreement signing in March, Walgreens has been officially purchased by private equity firm Sycamore Partners for $10 billion, per a press release. Part of the deal means that Walgreens Boots Alliance and its subsidiaries are split into five separate and privately-owned operations… While the $10 billion was heavily supported by Walgreens shareholders, some industry experts worry that this decision will ultimately lead to more layoffs and closures for the brand, per what they told Healthcare Brew. <Read More>

A Pharmacy Benefit Manager Stopped Covering a GLP-1 for Obesity. Now There’s a Lawsuit – September 6, 2025 – A class-action lawsuit has been filed against CVS Caremark over its decision to stop covering Zepbound®, Eli Lilly’s blockbuster GLP-1 drug to treat obesity. When the major pharmacy benefit manager informed patients about the change this year, it suggested that there was “another covered medication that’s safe and effective for your condition and may cost less”: namely Wegovy®, from Novo Nordisk, with which CVS Caremark announced a partnership just before the change took effect. <Read More> 

The Five Biggest Challenges Facing Retail Pharmacy – August 28, 2025 – Retail pharmacy operators face an array of challenges beyond PBM reform, which many observers say remains the single biggest obstacle to operating successfully in today’s environment. Among the most pressing issues is how the Medicare price negotiations that were included in the Inflation Reduction Act will play out at the retail level. Many retailers are concerned that reimbursement mechanisms might not be adequate to support their cash flow needs. In addition, the reimbursement models that evolve for GLP-1 drugs and other high-cost medications could also pose challenges for retailers. <Read More>

Getting a Covid Shot This Fall Could be a lot More Complicated – August 22, 2025 – The millions of Americans who are used to getting their Covid-19 vaccines at a local pharmacy may face new hurdles this fall depending on where they live and whether federal health officials have decided they qualify. Pharmacists’ authority to vaccinate individuals varies across state lines. In some places, it’s dependent upon a federal advisory process that Health Secretary Robert F. Kennedy Jr. has upended. <Read More> 

Determining if LAAO Will Benefit Patients With Afib Using Novel AI Algorithm – August 16, 2025 – Researchers in Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery in collaboration with Cardiovascular Medicine developed a new artificial intelligence (AI) algorithm to identify patients likely to benefit from transcatheter left atrial appendage occlusion (LAAO) versus direct oral anticoagulants (DOACs). This algorithm can help patients with atrial fibrillation (AFib) who need to be referred to a subspecialty for consultation. The findings were published in JACC: Clinical Electrophysiology. <Read More>

Costco to Not Sell Abortion Pill Mifepristone at its US Pharmacy Stores – August 15, 2025 – Costco Wholesale (COST.O), opens new tab said on Thursday it has decided to not sell abortion pill mifepristone across all its U.S. pharmacy stores, citing low demand. "Our position at this time not to sell mifepristone, which has not changed, is based on the lack of demand from our members and other patients, who we understand generally have the drug dispensed by their medical providers," Costco said. The decision comes amid campaigns against the pill by religious activist groups, including Inspire Investing and Alliance Defending Freedom. <Read More> 

House, Senate Bills Would Expand Pharmacists’ Scope of Practice – August 14, 2025 – H.R. 3164, the Ensuring Community Access to Pharmacist Services Act, has been sponsored by Rep. Adrian Smith (R-Neb.). The bill would amend the Social Security Act to allow Medicare payment for pharmacists to evaluate, diagnose and treat patients for a range of illnesses including COVID-19, respiratory syncytial virus (RSV) and streptococcal pharyngitis. The measure also would let pharmacists test and treat patients in response to an unspecified “public health need” related to a public health emergency. <Read More> 

Eli Lilly Accused of Bribing Providers to Prescribe GLP-1RA Drugs – August 13, 2025 – Despite posting record Q2 growth for its blockbuster weight loss and diabetes drug tirzepatide, Eli Lilly is facing legal challenge from a lawsuit filed in Texas that accuses the pharma company of bribing providers to prescribe its drugs.  Attorney General for Texas Ken Paxton and Health Choice Alliance claim Eli Lilly “offered illegal incentives” to medical providers in the southern state so its most profitable drugs, including popular glucagon-like peptide-1 receptor agonist (GLP-1RA) medications tirzepatide, marketed as Mounjaro® and Zepbound®, would be preferentially prescribed to patients. <Read More> 

An AI “Copilot” Can Reduce Prescription Errors That Put Patients at Risk – August 12, 2025 – “Take two aspirin and call me in the morning.” If only prescribing medications were as simple as that. In reality, the prescription process involves many players and steps. Details must be accurately spelled out, interpreted, and double-checked to ensure patients get the correct drug and dosage…With several collaborators at Amazon, Bayati developed an AI-based system for translating prescriptions with fewer errors. “An AI approach to this problem is a good choice because it’s capable of seeing patterns in prescription data and could flag prescriptions that match error-related patterns and write error-free ones,” Bayati says. <Read More>

340B in the News

AHA Accuses Drug Companies of Colluding to Impose 340B Rebate Plans – September 9, 2025 – The country’s largest hospital lobby is accusing five major drugmakers of secretly conspiring to transition to a rebate model in 340B, in the latest salvo between providers and pharmaceutical companies over the future of the drug discount program. On Monday, the American Hospital Association sent a letter to the heads of the Federal Trade Commission and the Justice Department’s antitrust division asking them to investigate Johnson & Johnson, Eli Lilly, Bristol Myers Squibb, Sanofi and Novartis for potential collusion. <Read More>

CBO Confirms 340B Drug Pricing Program Increases Costs for Federal Taxpayers – September 9, 2025 –  Congressman Brett Guthrie (KY-02), Chairman of the House Committee on Energy and Commerce, issued the following statement in response to the Congressional Budget Office’s (CBO) report released September 9th, which confirmed the 340B Drug Pricing Program encourages behaviors that increase federal spending and raise prices for American taxpayers. Some of those behaviors include incentivizing the prescription of more expensive drugs, reducing negotiated rebates for insurers, and increasing vertical integration among facilities. <Read More> 

Clinical Insights: February 6th, 2026

New Drug/Vaccine Approval

Yuvezzi™ (brimonidine tartrate and carbachol) Ophthalmic Solution - formerly Brimochol PF™ – New Drug Approval – January 28, 2026 – Tenpoint Therapeutics, Ltd., a global, commercial biotechnology company focused on developing groundbreaking treatments to improve vision in the aging eye, announced that the U.S. Food and Drug Administration (FDA) approved Yuvezzi™ (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1%, previously known as Brimochol PF™, the first and only dual-agent eye drop for the treatment of presbyopia in adults. <Read More> 

Zycubo™ (copper histidinate) Injection - formerly CUTX-101 – New Drug Approval – January 12, 2026 - The U.S. Food and Drug Administration approved the Zycubo™ (copper histidinate) injection as the first treatment for Menkes disease in pediatric patients. “With today’s action, children with this devastating, degenerative disease will have an FDA-approved treatment option and the potential to live longer,” said Christine Nguyen, M.D., Deputy Director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the FDA’s Center for Drug Evaluation and Research. “The FDA will continue to work with the rare disease community to advance drug development for patients with Menkes disease and other rare conditions.” <Read More>  

New Label Expansions

Darzalex Faspro® (daratumumab and hyaluronidase-fihj) Injection – New Label Expansion – January 27, 2026 – Johnson & Johnson (NYSE:JNJ) announced the U.S. Food and Drug Administration (FDA) approved Darzalex Faspro® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone (D-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT). D-VRd is the only anti-CD38 antibody-based regimen with approved indications across newly diagnosed patients, regardless of transplant eligibility. <Read More> 

Afrezza® (insulin human [rDNA origin]) Inhalation Powder - New Label Expansion – January 23, 2026 – MannKind Corporation (Nasdaq: MNKD), a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions for cardiometabolic and orphan lung diseases, announced that the U.S. Food and Drug Administration (FDA) has approved an update to the Prescribing Information for Afrezza® (insulin human) Inhalation Powder, revising recommendations for the starting mealtime dosage when patients switch from subcutaneous mealtime insulin regimens. <Read More>  

Nexplanon® (etonogestrel) Implant - New Label Expansion – January 16, 2026 - Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, announced that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Nexplanon® (etonogestrel implant), which is indicated for use by women of reproductive potential to prevent pregnancy. The sNDA extends the duration of use of Nexplanon® for up to five years, an extension of the previous three-year indication. <Read More>  

New Drug Shortage

January 30, 2026

January 28, 2026

January 27, 2026

January 20, 2026

January 13, 2026

Updated Drug Shortage

February 02, 2026

January 27, 2026

January 23, 2026

January 22, 2026

January 21, 2026

New Drug Recall and Safety Alerts

No new update.

Clinical and Pharmacy News

Prior Authorization Ranked Top Barrier to Health Care Access After Cost – February 2, 2026 – While the cost of health care remains the dominant worry among Americans, the process of obtaining prior authorization from insurers has become the most burdensome noncost barrier for insured adults trying to access care, according to a new KFF Health Tracking Poll released today. The findings underscore growing public frustration with insurance-driven obstacles that can delay, alter, or even block necessary medical services, treatments, and medications. <Read More>  

Why Pharmacy Transparency is Becoming a C-Suite Issue – January 29, 2026 – The U.S. healthcare industry is entering a pivotal moment in its debate over pharmacy benefit transparency, and HR executives—especially those overseeing self-insured health plans—are increasingly at the center of it. In Congress, lawmakers have introduced legislation aimed at improving visibility into how pharmacy benefit managers (PBMs) operate and how prescription drug prices are set, while a growing number of lawsuits challenge opaque pricing practices, rebate arrangements and whether plan sponsors exercised appropriate oversight. Public scrutiny is rising as well, with high-profile business figures like Mark Cuban using conference stages, media interviews and social channels to urge employers to demand greater transparency (an argument that aligns with his business interest in reshaping how prescription drugs are priced and purchased). And that pressure has reached PBMs themselves: As of 2025, the CEOs of the three largest PBMs have all publicly stated that rebates would be returned to customers. <Read More>

US Labor Department Proposes Rule to Boost Transparency in Pharmacy Benefit Manager Fees – January 29, 2026 - The U.S. Department of Labor's Employee Benefits Security Administration on Thursday issued a proposed rule aimed at increasing transparency around fees and compensation collected by pharmacy benefit managers. The move, which follows a directive under President Donald Trump's executive order on lowering drug prices, seeks to clarify PBM business practices that affect employer-sponsored health plans covering millions of Americans. <Read More> 

US Vaccine Guideline Changes Challenge Clinical Practice, Insurance Coverage – January 27, 2026 – Recent changes to routine vaccine recommendations have created confusion and uncertainty regarding public health guidance. These changes may limit or restrict access to certain vaccines due to a lack of availability or insurance coverage, which could increase costs. Clinicians are advised to provide opportunities to discuss the underlying scientific evidence supporting recommended vaccines. The American Academy of Pediatrics (AAP) no longer endorses the immunization schedule from the Centers for Disease Control and Prevention (CDC) and strongly recommends the full set of immunizations. <Read More> 

New Guideline Expands Stroke Treatment for Adults, Offers First Pediatric Stroke Guidance – January 26, 2026 – Expanded eligibility for advanced stroke therapies and new recommendations for diagnosing and treating stroke in children and adults are among the major updates in the new 2026 Guideline for the Early Management of Patients With Acute Ischemic Stroke from the American Stroke Association, a division of the American Heart Association, published in the Association’s flagship journal Stroke. <Read More>

New Clinical Practice Guideline Recognizes Insomnia and Sleep Apnea Can Occur Together – January 22, 2026 – Getting regular restorative sleep on a regular basis is essential to good health — yet studies have shown that lack of sleep has left the military less combat ready. To address this urgent issue, the Department of Defense and the Department of Veterans Affairs revised the Clinical Practice Guideline for the Management of Chronic Insomnia Disorder and Obstructive Sleep on July 29, 2025. The lack of restorative sleep is known as chronic insomnia disorder. Obstructive sleep apnea is characterized by repetitive snoring, choking, and awakenings. These two conditions often go together, resulting in sleepiness that affects service member duty performance and overall readiness, and can lead to serious physical and mental health consequences. <Read More>

How Specialty Pharmacists Can Keep HIV Patients on ART – January 21, 2026 – A team of specialty pharmacists and pharmacy liaisons in Brooklyn successfully transitioned a small group of patients living with HIV from daily oral antiviral therapy (ART) to injectable long-acting antiretroviral therapy (LA-ART). The switch improved medication access and adherence, and optimized treatment outcomes for HIV management and PrEP, the team reported at the NASP 2025 Annual Meeting & Expo, in Denver (poster OPR17-OR). Treatment shortcomings of oral ART, according to the poster, include daily pill fatigue, social stigma, and inconsistent access to medication. <Read More>

FDA Schedules Review Meeting After Gene Therapy Shows Slowing of Huntington’s Progression – January 13, 2026 – The FDA has scheduled a Type A meeting with uniQure to discuss materials supporting a potential accelerated approval pathway for AMT-130, the company’s investigational gene therapy for Huntington’s disease, reopening regulatory engagement after a setback in late 2025. In an announcement on Jan. 9, 2026, uniQure said the meeting will focus on its data supporting accelerated approval of AMT-130. The company said it expects to issue a further update after receiving official minutes. <Read More> 

340B in the News

A Win for Kids — And Why 340B Still Needs Defending – January 27, 2026 – Protecting the 340B Drug Pricing Program remains a top priority for the Children’s Hospital Association, and recent developments underscore the importance of our advocacy. Working closely with our member hospitals, we have taken action to safeguard 340B and the children’s hospitals that rely on it. Our efforts helped halt a pilot rebate program that would fundamentally alter how 340B operates and place an unsustainable financial burden on children’s hospitals. In January, a federal appeals court paused the proposed rebate program that would provide money back to hospitals after drugs were purchased. The administration dropped an appeal of the courts’ decision, allowing upfront discounts to continue. With the pilot rebate program now on an indefinite pause, CHA is building on that momentum to continue protecting this vital program. <Read More> 

Government Withdraws Appeal in 340B Rebate Pilot Program Litigation, Signaling Shift – January 27, 2026 – The recent litigation concerning the government’s 340B Rebate Model Pilot Program (the Rebate Program), as further described below, took an unexpected turn as the federal government recently signaled that it intended to revise its approach to the Rebate Program. This change in strategy was previewed by the government in a letter filed with the Court on January 12, 2026—the deadline for briefing regarding the preliminary injunction—stating that the government was considering “returning the approvals challenged [in the lawsuit] to [the Health Resources and Services Administration] for reconsideration,” and that the parties “plan to dismiss the appeal in short order.” The government formally moved to dismiss its appeal on January 16, 2026, and the First Circuit dismissed the appeal on January 20, 2026. <Read More>

AHA Urges HRSA to Stop Eli Lilly’s 340B Claims-Data Submission Policy from Going Into Effect  – January 26, 2026 – The urged the Health Resources and Services Administration to take immediate action to stop a new Eli Lilly and Company policy from taking effect on Feb. 1, including by “assessing civil monetary penalties for intentionally overcharging 340B hospitals.” On Jan. 15, Lilly issued a notice to all 340B covered entities that the company was updating its data requirements for its 340B distribution program. The policy would require 340B covered entities to submit claims data for all dispensations of all Lilly drugs, regardless of setting. <Read More> 

HRSA Announces 340B Rebate Model Pilot Program – January 23, 2026 – On August 1, 2025, the Health Resources and Services Administration (HRSA) released a federal register notice announcing its long-anticipated 340B rebate model guidance, which implements a relatively narrow pilot program focusing on drugs subject to Medicare drug price negotiations for 2026. While the pilot program is voluntary for manufacturers, covered entities will need to submit the required data to access the 340B price via rebate on selected drugs under approved manufacturer plans. The notice states the pilot model is intended to address the 340B and Inflation Reduction Act (IRA) maximum fair price (MFP) deduplication. The model requirements mention that rebates should not be denied based on compliance concerns with diversion or Medicaid duplicate discounts. <Read More> 


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Clinical Insights: February 6th, 2026

New Drug/Vaccine Approval

Yuvezzi™ (brimonidine tartrate and carbachol) Ophthalmic Solution - formerly Brimochol PF™ – New Drug Approval – January 28, 2026 – Tenpoint Therapeutics, Ltd., a global, commercial biotechnology company focused on developing groundbreaking treatments to improve vision in the aging eye, announced that the U.S. Food and Drug Administration (FDA) approved Yuvezzi™ (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1%, previously known as Brimochol PF™, the first and only dual-agent eye drop for the treatment of presbyopia in adults. <Read More> 

Zycubo™ (copper histidinate) Injection - formerly CUTX-101 – New Drug Approval – January 12, 2026 - The U.S. Food and Drug Administration approved the Zycubo™ (copper histidinate) injection as the first treatment for Menkes disease in pediatric patients. “With today’s action, children with this devastating, degenerative disease will have an FDA-approved treatment option and the potential to live longer,” said Christine Nguyen, M.D., Deputy Director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the FDA’s Center for Drug Evaluation and Research. “The FDA will continue to work with the rare disease community to advance drug development for patients with Menkes disease and other rare conditions.” <Read More>  

New Label Expansions

Darzalex Faspro® (daratumumab and hyaluronidase-fihj) Injection – New Label Expansion – January 27, 2026 – Johnson & Johnson (NYSE:JNJ) announced the U.S. Food and Drug Administration (FDA) approved Darzalex Faspro® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone (D-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT). D-VRd is the only anti-CD38 antibody-based regimen with approved indications across newly diagnosed patients, regardless of transplant eligibility. <Read More> 

Afrezza® (insulin human [rDNA origin]) Inhalation Powder - New Label Expansion – January 23, 2026 – MannKind Corporation (Nasdaq: MNKD), a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions for cardiometabolic and orphan lung diseases, announced that the U.S. Food and Drug Administration (FDA) has approved an update to the Prescribing Information for Afrezza® (insulin human) Inhalation Powder, revising recommendations for the starting mealtime dosage when patients switch from subcutaneous mealtime insulin regimens. <Read More>  

Nexplanon® (etonogestrel) Implant - New Label Expansion – January 16, 2026 - Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, announced that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Nexplanon® (etonogestrel implant), which is indicated for use by women of reproductive potential to prevent pregnancy. The sNDA extends the duration of use of Nexplanon® for up to five years, an extension of the previous three-year indication. <Read More>  

New Drug Shortage

January 30, 2026

January 28, 2026

January 27, 2026

January 20, 2026

January 13, 2026

Updated Drug Shortage

February 02, 2026

January 27, 2026

January 23, 2026

January 22, 2026

January 21, 2026

New Drug Recall and Safety Alerts

No new update.

Clinical and Pharmacy News

Prior Authorization Ranked Top Barrier to Health Care Access After Cost – February 2, 2026 – While the cost of health care remains the dominant worry among Americans, the process of obtaining prior authorization from insurers has become the most burdensome noncost barrier for insured adults trying to access care, according to a new KFF Health Tracking Poll released today. The findings underscore growing public frustration with insurance-driven obstacles that can delay, alter, or even block necessary medical services, treatments, and medications. <Read More>  

Why Pharmacy Transparency is Becoming a C-Suite Issue – January 29, 2026 – The U.S. healthcare industry is entering a pivotal moment in its debate over pharmacy benefit transparency, and HR executives—especially those overseeing self-insured health plans—are increasingly at the center of it. In Congress, lawmakers have introduced legislation aimed at improving visibility into how pharmacy benefit managers (PBMs) operate and how prescription drug prices are set, while a growing number of lawsuits challenge opaque pricing practices, rebate arrangements and whether plan sponsors exercised appropriate oversight. Public scrutiny is rising as well, with high-profile business figures like Mark Cuban using conference stages, media interviews and social channels to urge employers to demand greater transparency (an argument that aligns with his business interest in reshaping how prescription drugs are priced and purchased). And that pressure has reached PBMs themselves: As of 2025, the CEOs of the three largest PBMs have all publicly stated that rebates would be returned to customers. <Read More>

US Labor Department Proposes Rule to Boost Transparency in Pharmacy Benefit Manager Fees – January 29, 2026 - The U.S. Department of Labor's Employee Benefits Security Administration on Thursday issued a proposed rule aimed at increasing transparency around fees and compensation collected by pharmacy benefit managers. The move, which follows a directive under President Donald Trump's executive order on lowering drug prices, seeks to clarify PBM business practices that affect employer-sponsored health plans covering millions of Americans. <Read More> 

US Vaccine Guideline Changes Challenge Clinical Practice, Insurance Coverage – January 27, 2026 – Recent changes to routine vaccine recommendations have created confusion and uncertainty regarding public health guidance. These changes may limit or restrict access to certain vaccines due to a lack of availability or insurance coverage, which could increase costs. Clinicians are advised to provide opportunities to discuss the underlying scientific evidence supporting recommended vaccines. The American Academy of Pediatrics (AAP) no longer endorses the immunization schedule from the Centers for Disease Control and Prevention (CDC) and strongly recommends the full set of immunizations. <Read More> 

New Guideline Expands Stroke Treatment for Adults, Offers First Pediatric Stroke Guidance – January 26, 2026 – Expanded eligibility for advanced stroke therapies and new recommendations for diagnosing and treating stroke in children and adults are among the major updates in the new 2026 Guideline for the Early Management of Patients With Acute Ischemic Stroke from the American Stroke Association, a division of the American Heart Association, published in the Association’s flagship journal Stroke. <Read More>

New Clinical Practice Guideline Recognizes Insomnia and Sleep Apnea Can Occur Together – January 22, 2026 – Getting regular restorative sleep on a regular basis is essential to good health — yet studies have shown that lack of sleep has left the military less combat ready. To address this urgent issue, the Department of Defense and the Department of Veterans Affairs revised the Clinical Practice Guideline for the Management of Chronic Insomnia Disorder and Obstructive Sleep on July 29, 2025. The lack of restorative sleep is known as chronic insomnia disorder. Obstructive sleep apnea is characterized by repetitive snoring, choking, and awakenings. These two conditions often go together, resulting in sleepiness that affects service member duty performance and overall readiness, and can lead to serious physical and mental health consequences. <Read More>

How Specialty Pharmacists Can Keep HIV Patients on ART – January 21, 2026 – A team of specialty pharmacists and pharmacy liaisons in Brooklyn successfully transitioned a small group of patients living with HIV from daily oral antiviral therapy (ART) to injectable long-acting antiretroviral therapy (LA-ART). The switch improved medication access and adherence, and optimized treatment outcomes for HIV management and PrEP, the team reported at the NASP 2025 Annual Meeting & Expo, in Denver (poster OPR17-OR). Treatment shortcomings of oral ART, according to the poster, include daily pill fatigue, social stigma, and inconsistent access to medication. <Read More>

FDA Schedules Review Meeting After Gene Therapy Shows Slowing of Huntington’s Progression – January 13, 2026 – The FDA has scheduled a Type A meeting with uniQure to discuss materials supporting a potential accelerated approval pathway for AMT-130, the company’s investigational gene therapy for Huntington’s disease, reopening regulatory engagement after a setback in late 2025. In an announcement on Jan. 9, 2026, uniQure said the meeting will focus on its data supporting accelerated approval of AMT-130. The company said it expects to issue a further update after receiving official minutes. <Read More> 

340B in the News

A Win for Kids — And Why 340B Still Needs Defending – January 27, 2026 – Protecting the 340B Drug Pricing Program remains a top priority for the Children’s Hospital Association, and recent developments underscore the importance of our advocacy. Working closely with our member hospitals, we have taken action to safeguard 340B and the children’s hospitals that rely on it. Our efforts helped halt a pilot rebate program that would fundamentally alter how 340B operates and place an unsustainable financial burden on children’s hospitals. In January, a federal appeals court paused the proposed rebate program that would provide money back to hospitals after drugs were purchased. The administration dropped an appeal of the courts’ decision, allowing upfront discounts to continue. With the pilot rebate program now on an indefinite pause, CHA is building on that momentum to continue protecting this vital program. <Read More> 

Government Withdraws Appeal in 340B Rebate Pilot Program Litigation, Signaling Shift – January 27, 2026 – The recent litigation concerning the government’s 340B Rebate Model Pilot Program (the Rebate Program), as further described below, took an unexpected turn as the federal government recently signaled that it intended to revise its approach to the Rebate Program. This change in strategy was previewed by the government in a letter filed with the Court on January 12, 2026—the deadline for briefing regarding the preliminary injunction—stating that the government was considering “returning the approvals challenged [in the lawsuit] to [the Health Resources and Services Administration] for reconsideration,” and that the parties “plan to dismiss the appeal in short order.” The government formally moved to dismiss its appeal on January 16, 2026, and the First Circuit dismissed the appeal on January 20, 2026. <Read More>

AHA Urges HRSA to Stop Eli Lilly’s 340B Claims-Data Submission Policy from Going Into Effect  – January 26, 2026 – The urged the Health Resources and Services Administration to take immediate action to stop a new Eli Lilly and Company policy from taking effect on Feb. 1, including by “assessing civil monetary penalties for intentionally overcharging 340B hospitals.” On Jan. 15, Lilly issued a notice to all 340B covered entities that the company was updating its data requirements for its 340B distribution program. The policy would require 340B covered entities to submit claims data for all dispensations of all Lilly drugs, regardless of setting. <Read More> 

HRSA Announces 340B Rebate Model Pilot Program – January 23, 2026 – On August 1, 2025, the Health Resources and Services Administration (HRSA) released a federal register notice announcing its long-anticipated 340B rebate model guidance, which implements a relatively narrow pilot program focusing on drugs subject to Medicare drug price negotiations for 2026. While the pilot program is voluntary for manufacturers, covered entities will need to submit the required data to access the 340B price via rebate on selected drugs under approved manufacturer plans. The notice states the pilot model is intended to address the 340B and Inflation Reduction Act (IRA) maximum fair price (MFP) deduplication. The model requirements mention that rebates should not be denied based on compliance concerns with diversion or Medicaid duplicate discounts. <Read More> 


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Clinical Insights: January 15th, 2026

New Drug/Vaccine Approval

Nereus™ (tradipitant) Capsules – New Drug Approval – December 30, 2025 - Vanda – Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) announced that the U.S. Food and Drug Administration (FDA) has approved Nereus™ (tradipitant), an oral neurokinin-1 (NK-1) receptor antagonist, for the prevention of vomiting induced by motion. This approval marks the first new pharmacologic treatment in motion sickness in over four decades, representing a significant advancement in the understanding and management of this debilitating physiologic response that affects a substantial portion of the population and has long been recognized as a factor affecting military operational readiness. <Read More>

Yartemlea® (narsoplimab-wuug) Injection - New Drug Approval – December 23, 2025 – Omeros Corporation (NASDAQ: OMER) announced that the U.S. Food and Drug Administration (FDA) has approved Yartemlea® (narsoplimab-wuug) for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA), an often-fatal complication of stem-cell transplantation driven by activation of the lectin pathway of complement. Yartemlea® is the first and only approved lectin pathway inhibitor. <Read More>  

Aqvesme™ (mitapivat) Tablets - New Drug Approval – December 23, 2025 – Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, announced that the U.S. Food and Drug Administration (FDA) has approved Aqvesme™ (mitapivat), an oral pyruvate kinase (PK) activator, for the treatment of anemia in adults with alpha- or beta-thalassemia. <Read More> 

Myqorzo™ (aficamten) Tablets - New Drug Approval – December 19, 2025 – Cytokinetics, Incorporated (Nasdaq: CYTK) announced that the U.S. Food and Drug Administration (FDA) has approved Myqorzo™ (aficamten), 5 mg, 10 mg, 15 mg, 20 mg tablets for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms. Myqorzo™ is an allosteric and reversible inhibitor of cardiac myosin motor activity. In patients with oHCM, myosin inhibition with Myqorzo™ reduces cardiac contractility and left ventricular outflow tract (LVOT) obstruction. <Read More>  

Rybrevant Faspro™ (amivantamab and hyaluronidase-lpuj) Injection - New Drug Approval – December 17, 2025 – Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) approved Rybrevant Faspro™ (amivantamab and hyaluronidase-lpuj), the first and only subcutaneously (SC) administered therapy for patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). Rybrevant Faspro™ is approved across all indications of Rybrevant® (amivantamab-vmjw). <Read More> 

New Label Expansions

Cablivi® (caplacizumab-yhdp) Injection – New Label Expansion – December 23, 2025 – The U.S. Food and Drug Administration approved Cablivi® (caplacizumab-yhdp) for injection to treat pediatric patients 12 years and older with acquired thrombotic thrombocytopenic purpura (aTTP) in combination with plasma exchange and immunosuppressive therapy. Cablivi® was originally approved in 2019 to treat adults with this condition. <Read More> 

Furoscix® (furosemide) Injection – New Label Expansion – December 22, 2025 – MannKind Corporation (Nasdaq: MNKD) announced two business updates—approval of the Furoscix® (furosemide) On-body Infusor for pediatric patients and issuance of additional intellectual property protection for the investigational-stage Furoscix® ReadyFlow™ Autoinjector, which is currently under review by the U.S. FDA. <Read More>  

Wegovy® (semaglutide) Injection and Tablets – New Label Expansion – December 22, 2025 – Wegovy® pill is now available, providing those seeking help with their weight the revolutionary science of GLP-1 medicine in a pill for the first time. This advancement opens new possibilities for the more than 100 million Americans living with obesity. Wegovy® pill was approved on December 22, 2025 and is used with a reduced calorie diet and increased physical activity for adults with obesity, or with overweight who also have weight-related medical problems, to help them lose weight and keep it off. <Read More>  

ACCRUFeR® (ferric maltol) Capsules – New Label Expansion – December 19, 2025 – Shield Therapeutics plc (LSE: STX), a commercial-stage pharmaceutical company specialising in iron deficiency, announces that the US Food and Drug Administration (FDA), following a priority review of the clinical supplement, has approved the extension of the indication for ACCRUFeR® (ferric maltol) to include adolescents. ACCRUFeR® is now indicated for the treatment of iron deficiency in adult and pediatric patients 10 years of age and older. <Read More> 

Lunsumio Velo™ (mosunetuzumab-axgb) Injection – New Label Expansion – December 19, 2025 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced that the U.S. Food and Drug Administration (FDA) has approved CD20xCD3 bispecific Lunsumio Velo™ (mosunetuzumab-axgb), as a subcutaneous (SC) formulation, for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy, based on results from the Phase I/II GO29781 study. <Read More> 

Jascayd® (nerandomilast) Tablets – New Label Expansion – December 19, 2025 – Boehringer Ingelheim’s Jascayd® (nerandomilast) tablets has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of progressive pulmonary fibrosis (PPF) in adults. This represents a new treatment option in the U.S. for this debilitating lung condition, with Jascayd® being the first and only preferential phosphodiesterase 4B (PDE4B) inhibitor with immunomodulatory and antifibrotic effects approved in this indication. <Read More> 

Rubraca® (rucaparib) Tablets – New Label Expansion – December 17, 2025 - The Food and Drug Administration (FDA) approved rucaparib (Rubraca®, pharmaand GmbH) for adults with a deleterious BRCA mutation (BRCAm) (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) previously treated with an androgen receptor-directed therapy. Patients should be selected for therapy using an FDA-approved companion diagnostic (CDx). Rucaparib was granted accelerated approval in 2020 for a similar indication. <Read More> 

New Drug Shortage

January 12, 2026

January 09, 2026

January 08, 2026

January 06, 2026

January 05, 2026

Updated Drug Shortage

January 09, 2026

January 08, 2026

January 06, 2026

January 05, 2026

January 04, 2026

New Drug Recall and Safety Alerts

No new update.

New Generic/Biosimilar Approval and Launch

Boncresa™ (denosumab-mobz) Injection - New Prolia® Biosimilar Approval – December 19, 2025 – Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NASDAQ: AMRX) and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, announced that the U.S. Food and Drug Administration (FDA) has approved its Biologics Licensing Applications (BLAs) for Boncresa™ (denosumab-mobz), a biosimilar referencing Prolia®. <Read More> 

Oziltus™ (denosumab-mobz) Injection - New Xvega® Biosimilar Approval – December 19, 2025 – Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NASDAQ: AMRX) and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, announced that the U.S. Food and Drug Administration (FDA) has approved its Biologics Licensing Applications (BLAs) for…Oziltus™ (denosumab-mobz), a biosimilar referencing Xgeva®. <Read More> 

Nufymco® (ranibizumab-leyk) Injection - New Lucentis® Biosimilar Approval – December 18, 2025 – Formycon AG (FWB: FYB, Prime Standard, “Formycon”) and Bioeq AG (“Bioeq”) announce that the U.S. Food and Drug Administration (FDA) has approved Nufymco® (ranibizumab-leyk), an interchangeable biosimilar to Lucentis®. <Read More> 

Clinical and Pharmacy News

Asthma Management Clinical Practice Guideline Revisions Include Single-Inhaler Approach – January 13, 2026 – The Clinical Practice Guideline for the Primary Care Management of Asthma from the Department of Veterans Affairs and Department of Defense recommends using newer, fast-onset medications and one inhaler rather than two for maintenance and rescue needs. These combination medications are called Single Maintenance and Reliever Therapy, or SMART or MART, explained Maj. (Dr.) Jonathan Schroeder. He is chief of pediatric pulmonology and medical director of the Cystic Fibrosis Center at Brooke Army Medical Center in San Antonio, Texas. <Read More> 

National Pharmacy Benefit Manager Implements Direct-to-Consumer Model – January 12, 2026 – As the healthcare landscape rapidly evolves, the direct-to-consumer (DTC) model is transforming how Americans access prescription medications, putting price transparency, convenience and control directly into patients’ hands, while also lowering costs patients pay for prescription medications. Recognizing this shift, a major Pharmacy Benefit Manager (PBM) has taken a step by launching its own DTC Program Opportunity for network pharmacies. This initiative enables pharmacies to offer upfront, competitive DTC pricing at the point of sale, empowering patients to make informed choices about their healthcare while streamlining the prescription process for providers. By embracing this patient-centric model, the PBM is responding to changing consumer expectations. <Read More> 

What to Expect in US Healthcare in 2026 and Beyond – January 12, 2026 – The US healthcare system continues to face considerable financial strain, although there are pockets of opportunity. Industry EBITDA as a percentage of national health expenditures (NHE) fell from 11.2 percent in 2019 to 8.9 percent in 2024. In 2027, the picture is expected to worsen slightly, with industry EBITDA as a percentage of NHE expected to drop to 8.7 percent. <Read More> 

Industry Voices—Relational Technology: How FQHCs Bridge Specialty Care’s Missed Connections – January 9, 2026 – The challenge in community health isn’t just providing access to specialists; it’s also bridging the gap between primary and specialty care. Technology promises to transform clinical practice, but needs a human connection to produce transformative outcomes. To succeed at their mission, community health centers must embrace what I call relational technology—not tools but relationship multipliers that strengthen the bond between patient and provider. For the over 32 million federally qualified health center (FQHC) clients, largely from underserved populations, a referral to a specialist is often not a solution but rather the start of a confusing journey. <Read More> 

FDA Grants First Priority Voucher Approval to Augmentin XR™ – January 9, 2026 – The FDA approved Augmentin XR™ (amoxicillin-clavulanate potassium) to be manufactured by USAntibiotics under the Commissioner’s National Priority Voucher (CNPV) pilot program, marking the first time since the program was announced in June that a drug has been approved though the new review pathway. Augmentin XR™ is an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the beta-lactamase inhibitor clavulanate. The approval was completed in just two months, which the agency said “represent[s] a major reduction of the review timeline.” <Read More> 

CMS Proposes GLOBE and GUARD Drug Pricing Models to Reduce Medicare Costs – January 8, 2026 – CMS has proposed two mandatory Medicare drug pricing models: the GLOBE Model (for Part B drugs) and the GUARD Model (for Part D drugs). Both models would link Medicare drug rebate calculations to international pricing benchmarks from “economically comparable” countries. If finalized, the GLOBE and GUARD Models would create new and potentially significant rebate obligations for drug manufacturers. <Read More> 

WHO Releases Updated Recommendations on HIV Clinical Management – January 7, 2026 – The World Health Organization (WHO) has released updated recommendations on HIV clinical management providing new and revised guidance on antiretroviral therapy, management of vertical HIV transmission, and tuberculosis (TB) prevention for people living with HIV. These recommendations support an evidence-based, cost-effective approach to improving treatment outcomes, reducing HIV-related mortality and accelerating progress towards ending AIDS as a public health threat. <Read More> 

GLP-1 Coverage Expansion Under Medicare: What Digital Health Companies Need to Know – January 7, 2026 – The Trump administration has announced a pricing initiative designed to reduce the cost of glucagon-like peptide-1 (GLP-1) drug products for certain Medicare enrollees. This policy represents a significant departure from the administration’s prior position that Medicare and Medicaid would not cover anti-obesity medications, including GLP-1 products. The change is expected to influence market dynamics for both consumers and industry stakeholders, particularly telehealth companies. Telehealth providers and other digital health companies that have relied on lower-priced GLP-1 offerings as a competitive differentiator may face new challenges as Medicare pricing becomes more attractive to patients, especially as new products enter the market, such as a recent US Food and Drug Administration (FDA) approved oral GLP 1 pill. <Read More> 

Medical Experts Warn Federal Rollback of Childhood Vaccine Schedule Puts Children at Risk – January 7, 2026 – Medical and public health leaders expressed alarm after federal health officials announced sweeping changes to the U.S. childhood immunization schedule, an unprecedented move experts warn could accelerate the spread of vaccine-preventable diseases and dismantle decades of evidence-based vaccine policy. The Jan. 5 announcement by the CDC and the Department of Health and Human Services to revise long-standing childhood vaccine recommendations was finalized without public comment, marking a sharp departure from the transparent, science-driven process that has historically governed U.S. immunization guidance. <Read More> 

The 2026 Pharma Reset: How Industry Giants Are Navigating a New Era of Federal Price Controls – January 2, 2026 – January 1 marked the official commencement of the first-ever "Maximum Fair Prices" (MFPs) for ten of the most widely used drugs in the Medicare program, a direct result of the Inflation Reduction Act’s (IRA) negotiation provisions. This milestone represents a fundamental shift in the federal government’s role in drug pricing, moving from a passive payer to an active negotiator, and signaling the end of an era where manufacturers held unilateral pricing power for the duration of a drug's patent life. <Read More> 

340B in the News

340B Rebate Pilot Remains on Hold in Win for Hospitals – January 8, 2026 – The First Circuit Court of Appeals upheld the halt of the 340B rebate pilot on Wednesday, meaning the contentious payment experiment remains on hold as hospitals’ lawsuit seeking to block it progresses. Judges called the district court’s decision to pause the pilot “careful and thorough” in their Jan. 7 order, while noting that the Trump administration had failed to convince them it would succeed on the merits of its case. <Read More> 

Read More

Clinical Insights: January 15th, 2026

New Drug/Vaccine Approval

Nereus™ (tradipitant) Capsules – New Drug Approval – December 30, 2025 - Vanda – Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) announced that the U.S. Food and Drug Administration (FDA) has approved Nereus™ (tradipitant), an oral neurokinin-1 (NK-1) receptor antagonist, for the prevention of vomiting induced by motion. This approval marks the first new pharmacologic treatment in motion sickness in over four decades, representing a significant advancement in the understanding and management of this debilitating physiologic response that affects a substantial portion of the population and has long been recognized as a factor affecting military operational readiness. <Read More>

Yartemlea® (narsoplimab-wuug) Injection - New Drug Approval – December 23, 2025 – Omeros Corporation (NASDAQ: OMER) announced that the U.S. Food and Drug Administration (FDA) has approved Yartemlea® (narsoplimab-wuug) for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA), an often-fatal complication of stem-cell transplantation driven by activation of the lectin pathway of complement. Yartemlea® is the first and only approved lectin pathway inhibitor. <Read More>  

Aqvesme™ (mitapivat) Tablets - New Drug Approval – December 23, 2025 – Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, announced that the U.S. Food and Drug Administration (FDA) has approved Aqvesme™ (mitapivat), an oral pyruvate kinase (PK) activator, for the treatment of anemia in adults with alpha- or beta-thalassemia. <Read More> 

Myqorzo™ (aficamten) Tablets - New Drug Approval – December 19, 2025 – Cytokinetics, Incorporated (Nasdaq: CYTK) announced that the U.S. Food and Drug Administration (FDA) has approved Myqorzo™ (aficamten), 5 mg, 10 mg, 15 mg, 20 mg tablets for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms. Myqorzo™ is an allosteric and reversible inhibitor of cardiac myosin motor activity. In patients with oHCM, myosin inhibition with Myqorzo™ reduces cardiac contractility and left ventricular outflow tract (LVOT) obstruction. <Read More>  

Rybrevant Faspro™ (amivantamab and hyaluronidase-lpuj) Injection - New Drug Approval – December 17, 2025 – Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) approved Rybrevant Faspro™ (amivantamab and hyaluronidase-lpuj), the first and only subcutaneously (SC) administered therapy for patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). Rybrevant Faspro™ is approved across all indications of Rybrevant® (amivantamab-vmjw). <Read More> 

New Label Expansions

Cablivi® (caplacizumab-yhdp) Injection – New Label Expansion – December 23, 2025 – The U.S. Food and Drug Administration approved Cablivi® (caplacizumab-yhdp) for injection to treat pediatric patients 12 years and older with acquired thrombotic thrombocytopenic purpura (aTTP) in combination with plasma exchange and immunosuppressive therapy. Cablivi® was originally approved in 2019 to treat adults with this condition. <Read More> 

Furoscix® (furosemide) Injection – New Label Expansion – December 22, 2025 – MannKind Corporation (Nasdaq: MNKD) announced two business updates—approval of the Furoscix® (furosemide) On-body Infusor for pediatric patients and issuance of additional intellectual property protection for the investigational-stage Furoscix® ReadyFlow™ Autoinjector, which is currently under review by the U.S. FDA. <Read More>  

Wegovy® (semaglutide) Injection and Tablets – New Label Expansion – December 22, 2025 – Wegovy® pill is now available, providing those seeking help with their weight the revolutionary science of GLP-1 medicine in a pill for the first time. This advancement opens new possibilities for the more than 100 million Americans living with obesity. Wegovy® pill was approved on December 22, 2025 and is used with a reduced calorie diet and increased physical activity for adults with obesity, or with overweight who also have weight-related medical problems, to help them lose weight and keep it off. <Read More>  

ACCRUFeR® (ferric maltol) Capsules – New Label Expansion – December 19, 2025 – Shield Therapeutics plc (LSE: STX), a commercial-stage pharmaceutical company specialising in iron deficiency, announces that the US Food and Drug Administration (FDA), following a priority review of the clinical supplement, has approved the extension of the indication for ACCRUFeR® (ferric maltol) to include adolescents. ACCRUFeR® is now indicated for the treatment of iron deficiency in adult and pediatric patients 10 years of age and older. <Read More> 

Lunsumio Velo™ (mosunetuzumab-axgb) Injection – New Label Expansion – December 19, 2025 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced that the U.S. Food and Drug Administration (FDA) has approved CD20xCD3 bispecific Lunsumio Velo™ (mosunetuzumab-axgb), as a subcutaneous (SC) formulation, for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy, based on results from the Phase I/II GO29781 study. <Read More> 

Jascayd® (nerandomilast) Tablets – New Label Expansion – December 19, 2025 – Boehringer Ingelheim’s Jascayd® (nerandomilast) tablets has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of progressive pulmonary fibrosis (PPF) in adults. This represents a new treatment option in the U.S. for this debilitating lung condition, with Jascayd® being the first and only preferential phosphodiesterase 4B (PDE4B) inhibitor with immunomodulatory and antifibrotic effects approved in this indication. <Read More> 

Rubraca® (rucaparib) Tablets – New Label Expansion – December 17, 2025 - The Food and Drug Administration (FDA) approved rucaparib (Rubraca®, pharmaand GmbH) for adults with a deleterious BRCA mutation (BRCAm) (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) previously treated with an androgen receptor-directed therapy. Patients should be selected for therapy using an FDA-approved companion diagnostic (CDx). Rucaparib was granted accelerated approval in 2020 for a similar indication. <Read More> 

New Drug Shortage

January 12, 2026

January 09, 2026

January 08, 2026

January 06, 2026

January 05, 2026

Updated Drug Shortage

January 09, 2026

January 08, 2026

January 06, 2026

January 05, 2026

January 04, 2026

New Drug Recall and Safety Alerts

No new update.

New Generic/Biosimilar Approval and Launch

Boncresa™ (denosumab-mobz) Injection - New Prolia® Biosimilar Approval – December 19, 2025 – Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NASDAQ: AMRX) and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, announced that the U.S. Food and Drug Administration (FDA) has approved its Biologics Licensing Applications (BLAs) for Boncresa™ (denosumab-mobz), a biosimilar referencing Prolia®. <Read More> 

Oziltus™ (denosumab-mobz) Injection - New Xvega® Biosimilar Approval – December 19, 2025 – Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NASDAQ: AMRX) and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, announced that the U.S. Food and Drug Administration (FDA) has approved its Biologics Licensing Applications (BLAs) for…Oziltus™ (denosumab-mobz), a biosimilar referencing Xgeva®. <Read More> 

Nufymco® (ranibizumab-leyk) Injection - New Lucentis® Biosimilar Approval – December 18, 2025 – Formycon AG (FWB: FYB, Prime Standard, “Formycon”) and Bioeq AG (“Bioeq”) announce that the U.S. Food and Drug Administration (FDA) has approved Nufymco® (ranibizumab-leyk), an interchangeable biosimilar to Lucentis®. <Read More> 

Clinical and Pharmacy News

Asthma Management Clinical Practice Guideline Revisions Include Single-Inhaler Approach – January 13, 2026 – The Clinical Practice Guideline for the Primary Care Management of Asthma from the Department of Veterans Affairs and Department of Defense recommends using newer, fast-onset medications and one inhaler rather than two for maintenance and rescue needs. These combination medications are called Single Maintenance and Reliever Therapy, or SMART or MART, explained Maj. (Dr.) Jonathan Schroeder. He is chief of pediatric pulmonology and medical director of the Cystic Fibrosis Center at Brooke Army Medical Center in San Antonio, Texas. <Read More> 

National Pharmacy Benefit Manager Implements Direct-to-Consumer Model – January 12, 2026 – As the healthcare landscape rapidly evolves, the direct-to-consumer (DTC) model is transforming how Americans access prescription medications, putting price transparency, convenience and control directly into patients’ hands, while also lowering costs patients pay for prescription medications. Recognizing this shift, a major Pharmacy Benefit Manager (PBM) has taken a step by launching its own DTC Program Opportunity for network pharmacies. This initiative enables pharmacies to offer upfront, competitive DTC pricing at the point of sale, empowering patients to make informed choices about their healthcare while streamlining the prescription process for providers. By embracing this patient-centric model, the PBM is responding to changing consumer expectations. <Read More> 

What to Expect in US Healthcare in 2026 and Beyond – January 12, 2026 – The US healthcare system continues to face considerable financial strain, although there are pockets of opportunity. Industry EBITDA as a percentage of national health expenditures (NHE) fell from 11.2 percent in 2019 to 8.9 percent in 2024. In 2027, the picture is expected to worsen slightly, with industry EBITDA as a percentage of NHE expected to drop to 8.7 percent. <Read More> 

Industry Voices—Relational Technology: How FQHCs Bridge Specialty Care’s Missed Connections – January 9, 2026 – The challenge in community health isn’t just providing access to specialists; it’s also bridging the gap between primary and specialty care. Technology promises to transform clinical practice, but needs a human connection to produce transformative outcomes. To succeed at their mission, community health centers must embrace what I call relational technology—not tools but relationship multipliers that strengthen the bond between patient and provider. For the over 32 million federally qualified health center (FQHC) clients, largely from underserved populations, a referral to a specialist is often not a solution but rather the start of a confusing journey. <Read More> 

FDA Grants First Priority Voucher Approval to Augmentin XR™ – January 9, 2026 – The FDA approved Augmentin XR™ (amoxicillin-clavulanate potassium) to be manufactured by USAntibiotics under the Commissioner’s National Priority Voucher (CNPV) pilot program, marking the first time since the program was announced in June that a drug has been approved though the new review pathway. Augmentin XR™ is an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the beta-lactamase inhibitor clavulanate. The approval was completed in just two months, which the agency said “represent[s] a major reduction of the review timeline.” <Read More> 

CMS Proposes GLOBE and GUARD Drug Pricing Models to Reduce Medicare Costs – January 8, 2026 – CMS has proposed two mandatory Medicare drug pricing models: the GLOBE Model (for Part B drugs) and the GUARD Model (for Part D drugs). Both models would link Medicare drug rebate calculations to international pricing benchmarks from “economically comparable” countries. If finalized, the GLOBE and GUARD Models would create new and potentially significant rebate obligations for drug manufacturers. <Read More> 

WHO Releases Updated Recommendations on HIV Clinical Management – January 7, 2026 – The World Health Organization (WHO) has released updated recommendations on HIV clinical management providing new and revised guidance on antiretroviral therapy, management of vertical HIV transmission, and tuberculosis (TB) prevention for people living with HIV. These recommendations support an evidence-based, cost-effective approach to improving treatment outcomes, reducing HIV-related mortality and accelerating progress towards ending AIDS as a public health threat. <Read More> 

GLP-1 Coverage Expansion Under Medicare: What Digital Health Companies Need to Know – January 7, 2026 – The Trump administration has announced a pricing initiative designed to reduce the cost of glucagon-like peptide-1 (GLP-1) drug products for certain Medicare enrollees. This policy represents a significant departure from the administration’s prior position that Medicare and Medicaid would not cover anti-obesity medications, including GLP-1 products. The change is expected to influence market dynamics for both consumers and industry stakeholders, particularly telehealth companies. Telehealth providers and other digital health companies that have relied on lower-priced GLP-1 offerings as a competitive differentiator may face new challenges as Medicare pricing becomes more attractive to patients, especially as new products enter the market, such as a recent US Food and Drug Administration (FDA) approved oral GLP 1 pill. <Read More> 

Medical Experts Warn Federal Rollback of Childhood Vaccine Schedule Puts Children at Risk – January 7, 2026 – Medical and public health leaders expressed alarm after federal health officials announced sweeping changes to the U.S. childhood immunization schedule, an unprecedented move experts warn could accelerate the spread of vaccine-preventable diseases and dismantle decades of evidence-based vaccine policy. The Jan. 5 announcement by the CDC and the Department of Health and Human Services to revise long-standing childhood vaccine recommendations was finalized without public comment, marking a sharp departure from the transparent, science-driven process that has historically governed U.S. immunization guidance. <Read More> 

The 2026 Pharma Reset: How Industry Giants Are Navigating a New Era of Federal Price Controls – January 2, 2026 – January 1 marked the official commencement of the first-ever "Maximum Fair Prices" (MFPs) for ten of the most widely used drugs in the Medicare program, a direct result of the Inflation Reduction Act’s (IRA) negotiation provisions. This milestone represents a fundamental shift in the federal government’s role in drug pricing, moving from a passive payer to an active negotiator, and signaling the end of an era where manufacturers held unilateral pricing power for the duration of a drug's patent life. <Read More> 

340B in the News

340B Rebate Pilot Remains on Hold in Win for Hospitals – January 8, 2026 – The First Circuit Court of Appeals upheld the halt of the 340B rebate pilot on Wednesday, meaning the contentious payment experiment remains on hold as hospitals’ lawsuit seeking to block it progresses. Judges called the district court’s decision to pause the pilot “careful and thorough” in their Jan. 7 order, while noting that the Trump administration had failed to convince them it would succeed on the merits of its case. <Read More> 

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Clinical Insights: December 23rd, 2025

New Drug/Vaccine Approval

Exdensur™ (depemokimab-ulaa) Injection - New Drug Approval – December 16, 2025 - GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has approved Exdensur™ (depemokimab-ulaa) as an add-on maintenance treatment of severe asthma characterised by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older. <Read More>

Cardamyst™ (etripamil) Nasal Spray – New Drug Approval – December 12, 2025 – Milestone Pharmaceuticals Inc.  (Nasdaq: MIST) announced that the U.S. Food and Drug Administration (FDA) approved its first commercial product, Cardamyst™ (etripamil) nasal spray, a prescription medication for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. This approval marks the first time that more than two million Americans with PSVT will have a rapid-acting treatment option they can self-administer outside the emergency department or other healthcare setting. Cardamyst™ is expected to be available in retail pharmacies in the first quarter of 2026. <Read More> 

Nuzolvence® (zoliflodacin) Granules for Oral Suspension - New Drug Approval – December 12, 2025 – Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (NASDAQ: INVA), announced that the U.S. Food and Drug Administration (FDA) has approved Nuzolvence® (zoliflodacin) for oral suspension, a first-in-class, single-dose oral medication for the treatment of uncomplicated urogenital gonorrhea in adults and pediatric patients 12 years and older weighing at least 35 kg. <Read More> 

Waskyra™ (etuvetidigene autotemcel) Suspension for Intravenous Infusion - New Drug Approval – December 9, 2025 - The U.S. Food and Drug Administration approved Waskyra™ (etuvetidigene autotemcel), the first cell-based gene therapy for the treatment of Wiskott-Aldrich syndrome (WAS). Waskyra™ is indicated for pediatric patients six months and older and adults with WAS who have a mutation in the WAS gene and for whom hematopoietic stem cell transplantation (HSCT) is appropriate and no suitable human leukocyte antigen (HLA)-matched related stem cell donor is available. <Read More> 

Avance™ (acellular nerve allograft-arwx) for Surgical Implantation - New Drug Approval – December 3, 2025 – The U.S. Food and Drug Administration granted approval for Avance™ (acellular nerve allograft-arwx) in surgical implantation. Avance™ is a peripheral nerve scaffold approved for sensory nerve discontinuities (≤25mm) (breaks in the pathway of sensory nerves) in adults and pediatric patients aged one month and older. Under the Accelerated Approval pathway, Avance™ is also approved for larger sensory nerve discontinuities (>25mm), motor and mixed nerve discontinuities. <Read More> 

Voyxact® (sibeprenlimab-szsi) Injection - New Drug Approval – November 25, 2025 – Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical, Co. Ltd. (Otsuka) announce the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Voyxact® (sibeprenlimab-szsi) for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. <Read More> 

Itvisma® (onasemnogene abeparvovec-brve) Suspension for Intrathecal Injection - New Drug Approval – November 24, 2025 – Novartis announced that the US Food and Drug Administration (FDA) has approved Itvisma® (onasemnogene abeparvovec-brve) for the treatment of children two years and older, teens and adults living with spinal muscular atrophy (SMA) with a confirmed mutation in the survival motor neuron 1 (SMN1) gene, making it the first and only gene replacement therapy available for this broad population. Itvisma® is uniquely designed to address the genetic root cause of SMA with a one-time fixed dose that does not need to be adjusted for age or body weight. By replacing the SMN1 gene, Itvisma® can improve motor function, offering the potential to reduce the need for chronically administered treatment associated with other available therapies for this population. <Read More> 

Hyrnuo® (sevabertinib) Tablets - New Drug Approval – November 18, 2025 – The Food and Drug Administration granted accelerated approval to sevabertinib (Hyrnuo®, Bayer HealthCare Pharmaceuticals Inc.), a kinase inhibitor, for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. <Read More> 

Redemplo® (plozasiran) Injection - New Drug Approval – November 18, 2025 – Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) announced that the U.S. Food and Drug Administration (FDA) has approved Redemplo® (plozasiran), a small interfering RNA (siRNA) medicine, as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS). FCS is a severe, rare disease, with an estimated 6,500 people in the U.S. living with genetic or clinical FCS, characterized by triglyceride levels that can be 10 to 100 times higher than normal leading to a substantially higher risk of developing acute, recurrent, and potentially fatal pancreatitis. <Read More> 

New Label Expansions

Enhertu® (fam-trastuzumab deruxtecan-nxki) Injection – New Label Expansion – December 15, 2025 - AstraZeneca and Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan) in combination with pertuzumab has been approved in the US for the 1st-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer, as determined by a Food and Drug Administration (FDA)-approved test. <Read More> 

Addyi® (flibanserin) Tablets – New Label Expansion – December 13, 2025 - Sprout Pharmaceuticals announced a monumental milestone for women's health: the U.S. Food and Drug Administration (FDA) has approved Addyi® (flibanserin 100 mg) for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in women <65 years. This long-awaited decision closes a gap in care for millions of postmenopausal women experiencing frustrating low sexual desire and marks a historic first approval for the FDA. <Read More> 

Akeega® (abiraterone acetate and niraparib) Tablets – New Label Expansion – December 12, 2025 – Johnson & Johnson (NYSE:JNJ) announced the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Akeega® (niraparib and abiraterone acetate dual-action tablet) plus prednisone for the treatment of patients with BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC). <Read More> 

Orladeyo® (berotralstat) Capsules and Oral Pellets - New Label Expansion – December 2, 2025 – BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for the use of an oral pellet formulation of once-daily Orladeyo® (berotralstat) for prophylactic therapy in pediatric patients with hereditary angioedema (HAE) aged 2 to <12 years. <Read More> 

Uplizna® (inebilizumab-cdon) Injection - New Label Expansion – December 11, 2025 – Amgen (NASDAQ: AMGN) announced that the U.S. Food and Drug Administration (FDA) has approved Uplizna® (inebilizumab-cdon) for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) and anti-muscle specific tyrosine kinase (MuSK) antibody positive. The approval offers patients a new targeted treatment option that has the potential for long-term disease control with just two doses a year, after two initial loading doses. <Read More> 

Daybue® (trofinetide) Oral Solution and Powder for Oral Solution - New Label Expansion – December 11, 2025 – Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) announced that the U.S. Food and Drug Administration (FDA) has approved Daybue® Stix (trofinetide) for oral solution, a dye- and preservative-free powder formulation of trofinetide for the treatment of Rett syndrome in adult and pediatric patients two years of age and older. <Read More> 

Blujepa® (gepotidacin) Tablets - New Label Expansion – December 11, 2025 – GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application for gepotidacin as an oral option for adult and pediatric patients from 12 years of age weighing at least 45 kg who have limited or no alternative options for the treatment of uncomplicated urogenital gonorrhea caused by susceptible strains of Neisseria gonorrhoeae (e.g., where standard of care is contraindicated, or where patients are intolerant or unwilling to use first line treatment). <Read More> 

Omisirge® (omidubicel-onlv) Suspension for Infusion - New Label Expansion – December 5, 2025 – The U.S. Food and Drug Administration announced it has approved Omisirge® (omidubicel-onlv), the first hematopoietic stem cell transplant (HSCT) therapy to treat patients with severe aplastic anemia (SAA). Omisirge® is indicated for adults and pediatric patients 12 years and older with hematologic malignancies and now is approved for adults and pediatric patients six years and older with SAA following reduced intensity conditioning and for whom a compatible donor is not available.  <Read More> 

Breyanzi® (lisocabtagene maraleucel) Suspension for Intravenous Infusion - New Label Expansion – December 4, 2025 – Bristol Myers Squibb (NYSE: BMY) announced that the U.S. Food and Drug Administration (FDA) has granted approval of Breyanzi® (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy. <Read More> 

Jaypirca® (pirtobrutinib) Tablets - New Label Expansion – December 2, 2025 – The Food and Drug Administration granted traditional approval to pirtobrutinib (Jaypirca®, Eli Lilly and Company) for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor. In 2023, FDA granted accelerated approval to pirtobrutinib for adults with CLL/SLL who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor. <Read More> 

Omlyclo® (omalizumab-igec) Injection - New Label Expansion – December 1, 2025 – Celltrion, Inc. announced the U.S. Food and Drug Administration (FDA) has approved a new presentation of Omlyclo® (omalizumab-igec), the first and only biosimilar designated as interchangeable with Xolair® (omalizumab), in a 300mg/2mL solution in a single-dose prefilled syringe for subcutaneous injection. In the U.S., Omlyclo® will be marketed and distributed exclusively by Celltrion USA, Inc. <Read More> 

Imfinzi® (durvalumab) Injection - New Label Expansion – November 25, 2025 – AstraZeneca’s Imfinzi® (durvalumab) in combination with standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) has been approved in the US for the treatment of adult patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers. The approved regimen includes neoadjuvant Imfinzi in combination with chemotherapy before surgery, followed by adjuvant Imfinzi in combination with chemotherapy, then Imfinzi® monotherapy. <Read More> 

Keytruda® (pembrolizumab) for Injection - New Label Expansion – November 21, 2025 – The Food and Drug Administration approved pembrolizumab (Keytruda®, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex®, Merck) with enfortumab vedotin-ejfv (Padcev®, Astellas Pharma) as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin. <Read More> 

Koselugo® (selumetinib) Capsules and Oral Granules - New Label Expansion – November 19, 2025 – The Food and Drug Administration approved selumetinib (Koselugo®, AstraZeneca Pharmaceuticals LP) for adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). FDA previously approved selumetinib capsules and granules for pediatric patients 1 year of age and older for this indication. <Read More> 

Darzalex Faspro® (daratumumab and hyaluronidase-fihj) Injection - New Label Expansion – November 19, 2025 – The Food and Drug Administration granted traditional approval to daratumumab and hyaluronidase-fihj (Darzalex Faspro®, Janssen Biotech Inc.) with bortezomib, cyclophosphamide, and dexamethasone (VCd) for newly diagnosed light chain (AL) amyloidosis. FDA granted accelerated approval for this indication in 2021. <Read More> 

Eylea HD® (aflibercept) Injection - New Label Expansion – November 19, 2025 – Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the U.S. Food and Drug Administration (FDA) has approved Eylea HD® (aflibercept) Injection 8 mg for the treatment of patients with macular edema following retinal vein occlusion (RVO) with up to every 8-week dosing after an initial monthly dosing period. <Read More> 

Imdelltra™ (tarlatamab-dlle) for Injection - New Label Expansion – November 19, 2025 – The Food and Drug Administration granted traditional approval to tarlatamab-dlle (Imdelltra™, Amgen Inc.) for adults with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. Tarlatamab-dlle received accelerated approval for this indication in 2024. <Read More> 

Epkinly™ (epcoritamab-bysp) Injection - New Label Expansion – November 18, 2025 – The Food and Drug Administration approved epcoritamab-bysp (Epkinly™, Genmab US, Inc.) with lenalidomide and rituximab for relapsed or refractory follicular lymphoma (FL). The FDA also granted traditional approval to epcoritamab-bysp as monotherapy for relapsed or refractory FL after two or more lines of systemic therapy (epcoritamab-bysp was granted accelerated approval for this indication in 2024). <Read More> 

New Drug Shortage

December 10, 2025

December 08, 2025

December 04, 2025

December 03, 2025

December 02, 2025

Updated Drug Shortage

December 17, 2025

December 16, 2025

December 15, 2025

December 12, 2025

December 11, 2025

New Drug Recall and Safety Alerts

No new update.

New Generic/Biosimilar Approval and Launch

Armlupeg™ (pegfilgrastim-unne) Injection - New Neulasta® Biosimilar Approval – November 28, 2025 – Global pharma major Lupin Limited (Lupin), announced that the United States Food and Drug Administration (U.S. FDA) has approved Armlupeg™ (pegfilgrastim-unne) 6 mg/0.6 mL injection for subcutaneous use in a single-dose prefilled syringe, as biosimilar to Neulasta® (pegfilgrastim) 6 mg/0.6 mL injection. The product will be manufactured at Lupin’s Biotech facility in Pune, which was inspected by the U.S. FDA prior to approval. <Read More> 

Clinical and Pharmacy News

More Than 6,000 Medical Errors Every Year – December 18, 2025 - More than 20,000 cases of adverse medical events have been reported in our country over the past eight years, while more than 1,000 cases have reached the courts and received final rulings. The majority of these rulings vindicate those who filed claims after a medical error caused significant physical or psychological harm to themselves or their loved ones — and in some cases, the error even led to death. <Read More> 

Combination Pills for High Blood Pressure May Simplify Treatment, Improve Long-Term Health – December 15, 2025 – Taking one pill that combines two or more blood pressure medications may help adults with high blood pressure (also known as hypertension) lower their blood pressure level faster and more effectively than taking multiple medications separately, and it may also reduce the risk of heart attack and stroke, according to a new scientific statement published in the American Heart Association’s journal Hypertension. <Read More> 

Caring for Patients with Monkeypox – December 12, 2025 – Regardless of clade, monkeypox can be spread, treated, and prevented the same way. Most monkeypox patients without severe immunocompromise will recover with supportive care and pain control only. CDC's interim clinical guidance may assist clinicians in managing patients who have or are at risk for severe manifestations of monkeypox. There are no FDA-approved treatments specifically for monkeypox, but there are FDA-regulated medications that may help. <Read More> 

New Guidelines Recommend Nerve Blocks for Migraine ER Treatment – December 11, 2025 – People hospitalized for a debilitating migraine should receive targeted nerve blocks rather than IV opioids to quell their pain, a major update of treatment guidelines suggests. Doctors should use a nerve block injection to stop pain signals from thrumming through the occipital nerves located near the top of the spine, a report published in Headache: The Journal of Head and Face Pain, said. <Read More> 

Pharmacy and PBM Enforcement Trends: False Claims Act Risks in 2025 – December 11, 2025 – Pharmacy benefit managers (PBMs) manage prescription coverage for health plans and big employers. They decide which medicines are covered and at what price, negotiate discounts with drug makers, and set prices for pharmacies…Taken together, these matters demonstrate a renewed focus on pharmacy-related fraud. And while the financial recoveries differ dramatically, from hundreds of millions against national chains to a six-figure settlement against a small, independent pharmacy, the message is the same: Pharmacies and PBMs sit squarely in the DOJ’s enforcement sights. <Read More> 

ISMP Announces New Medication Safety Best Practices – December 11, 2025 – Improving safety with IV push medications, optimizing use of scanning machine-readable codes on patient identification bands and products, and improving the culture of safety are three new Targeted Medication Safety Best Practices suggested by the Institute for Safe Medication Practices (ISMP) for 2026-2027. These add to the 22 Best Practices suggested for 2024-2025, said Christina Michalek, RPh, FASHP, the director of membership and patient safety organization at ISMP, during a presentation at the ASHP Midyear 2025 Clinical Meeting & Exhibition, in Las Vegas. ISMP also updated two existing Best Practices: to add patient weights in electronic prescriptions and discharge and after-visit summaries, and to enhance medication reconciliation policies at hospital admission during transitions of care and at discharge. <Read More> 

FDA Warns Consumers Not to Use Counterfeit Ozempic® (Semaglutide) Found in U.S. Drug Supply Chain – December 5, 2025 – FDA recently seized dozens of units of counterfeit Ozempic® (semaglutide) injection 1 mg that were distributed illegally outside of Novo Nordisk's authorized supply chain. The seized counterfeit products were in the legitimate U.S. drug supply chain. The counterfeit products are labeled with lot number - PAR1229 - which also is an authentic lot number. <Read More> 

340B in the News

A New Call for 340B Transparency, Reform – December 12, 2025 – In a hearing that was at once contentious and unusually bipartisan, members of the Senate Health, Education, Labor and Pensions (HELP) Committee called for stronger oversight of the federal 340B Drug Discount Program while emphasizing its continued importance to safety-net hospitals and clinics. Witnesses from the Government Accountability Office (GAO), the Congressional Budget Office (CBO), and academic medicine testified on Oct. 23 that the program, intended to help hospitals stretch scarce financial resources, has grown exponentially while oversight has not kept pace. Senators from both parties urged reform but warned against changes that could undermine access to care for rural and underserved populations. <Read More> 

340B Discounts at Risk in 2025 and Beyond – December 12, 2025 – The 340B Drug Pricing Program faces intensifying scrutiny and legal battles at both state and federal levels in 2025. Pharmacy benefit managers (PBMs) are tightening point-of-sale claim identification, states are enacting anti-discrimination protections, and covered entities are waiting for the next shoe to drop. “Depending on who you’re speaking with, 340B is either the greatest thing since sliced bread—or Lord Voldemort himself,” said Jesse Dresser, Esq, a partner in Frier Levitt’s Life Sciences Department who heads the firm’s pharmacy practice group. <Read More> 

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Clinical Insights: December 23rd, 2025

New Drug/Vaccine Approval

Exdensur™ (depemokimab-ulaa) Injection - New Drug Approval – December 16, 2025 - GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has approved Exdensur™ (depemokimab-ulaa) as an add-on maintenance treatment of severe asthma characterised by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older. <Read More>

Cardamyst™ (etripamil) Nasal Spray – New Drug Approval – December 12, 2025 – Milestone Pharmaceuticals Inc.  (Nasdaq: MIST) announced that the U.S. Food and Drug Administration (FDA) approved its first commercial product, Cardamyst™ (etripamil) nasal spray, a prescription medication for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. This approval marks the first time that more than two million Americans with PSVT will have a rapid-acting treatment option they can self-administer outside the emergency department or other healthcare setting. Cardamyst™ is expected to be available in retail pharmacies in the first quarter of 2026. <Read More> 

Nuzolvence® (zoliflodacin) Granules for Oral Suspension - New Drug Approval – December 12, 2025 – Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (NASDAQ: INVA), announced that the U.S. Food and Drug Administration (FDA) has approved Nuzolvence® (zoliflodacin) for oral suspension, a first-in-class, single-dose oral medication for the treatment of uncomplicated urogenital gonorrhea in adults and pediatric patients 12 years and older weighing at least 35 kg. <Read More> 

Waskyra™ (etuvetidigene autotemcel) Suspension for Intravenous Infusion - New Drug Approval – December 9, 2025 - The U.S. Food and Drug Administration approved Waskyra™ (etuvetidigene autotemcel), the first cell-based gene therapy for the treatment of Wiskott-Aldrich syndrome (WAS). Waskyra™ is indicated for pediatric patients six months and older and adults with WAS who have a mutation in the WAS gene and for whom hematopoietic stem cell transplantation (HSCT) is appropriate and no suitable human leukocyte antigen (HLA)-matched related stem cell donor is available. <Read More> 

Avance™ (acellular nerve allograft-arwx) for Surgical Implantation - New Drug Approval – December 3, 2025 – The U.S. Food and Drug Administration granted approval for Avance™ (acellular nerve allograft-arwx) in surgical implantation. Avance™ is a peripheral nerve scaffold approved for sensory nerve discontinuities (≤25mm) (breaks in the pathway of sensory nerves) in adults and pediatric patients aged one month and older. Under the Accelerated Approval pathway, Avance™ is also approved for larger sensory nerve discontinuities (>25mm), motor and mixed nerve discontinuities. <Read More> 

Voyxact® (sibeprenlimab-szsi) Injection - New Drug Approval – November 25, 2025 – Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical, Co. Ltd. (Otsuka) announce the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Voyxact® (sibeprenlimab-szsi) for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. <Read More> 

Itvisma® (onasemnogene abeparvovec-brve) Suspension for Intrathecal Injection - New Drug Approval – November 24, 2025 – Novartis announced that the US Food and Drug Administration (FDA) has approved Itvisma® (onasemnogene abeparvovec-brve) for the treatment of children two years and older, teens and adults living with spinal muscular atrophy (SMA) with a confirmed mutation in the survival motor neuron 1 (SMN1) gene, making it the first and only gene replacement therapy available for this broad population. Itvisma® is uniquely designed to address the genetic root cause of SMA with a one-time fixed dose that does not need to be adjusted for age or body weight. By replacing the SMN1 gene, Itvisma® can improve motor function, offering the potential to reduce the need for chronically administered treatment associated with other available therapies for this population. <Read More> 

Hyrnuo® (sevabertinib) Tablets - New Drug Approval – November 18, 2025 – The Food and Drug Administration granted accelerated approval to sevabertinib (Hyrnuo®, Bayer HealthCare Pharmaceuticals Inc.), a kinase inhibitor, for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. <Read More> 

Redemplo® (plozasiran) Injection - New Drug Approval – November 18, 2025 – Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) announced that the U.S. Food and Drug Administration (FDA) has approved Redemplo® (plozasiran), a small interfering RNA (siRNA) medicine, as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS). FCS is a severe, rare disease, with an estimated 6,500 people in the U.S. living with genetic or clinical FCS, characterized by triglyceride levels that can be 10 to 100 times higher than normal leading to a substantially higher risk of developing acute, recurrent, and potentially fatal pancreatitis. <Read More> 

New Label Expansions

Enhertu® (fam-trastuzumab deruxtecan-nxki) Injection – New Label Expansion – December 15, 2025 - AstraZeneca and Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan) in combination with pertuzumab has been approved in the US for the 1st-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer, as determined by a Food and Drug Administration (FDA)-approved test. <Read More> 

Addyi® (flibanserin) Tablets – New Label Expansion – December 13, 2025 - Sprout Pharmaceuticals announced a monumental milestone for women's health: the U.S. Food and Drug Administration (FDA) has approved Addyi® (flibanserin 100 mg) for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in women <65 years. This long-awaited decision closes a gap in care for millions of postmenopausal women experiencing frustrating low sexual desire and marks a historic first approval for the FDA. <Read More> 

Akeega® (abiraterone acetate and niraparib) Tablets – New Label Expansion – December 12, 2025 – Johnson & Johnson (NYSE:JNJ) announced the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Akeega® (niraparib and abiraterone acetate dual-action tablet) plus prednisone for the treatment of patients with BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC). <Read More> 

Orladeyo® (berotralstat) Capsules and Oral Pellets - New Label Expansion – December 2, 2025 – BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for the use of an oral pellet formulation of once-daily Orladeyo® (berotralstat) for prophylactic therapy in pediatric patients with hereditary angioedema (HAE) aged 2 to <12 years. <Read More> 

Uplizna® (inebilizumab-cdon) Injection - New Label Expansion – December 11, 2025 – Amgen (NASDAQ: AMGN) announced that the U.S. Food and Drug Administration (FDA) has approved Uplizna® (inebilizumab-cdon) for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) and anti-muscle specific tyrosine kinase (MuSK) antibody positive. The approval offers patients a new targeted treatment option that has the potential for long-term disease control with just two doses a year, after two initial loading doses. <Read More> 

Daybue® (trofinetide) Oral Solution and Powder for Oral Solution - New Label Expansion – December 11, 2025 – Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) announced that the U.S. Food and Drug Administration (FDA) has approved Daybue® Stix (trofinetide) for oral solution, a dye- and preservative-free powder formulation of trofinetide for the treatment of Rett syndrome in adult and pediatric patients two years of age and older. <Read More> 

Blujepa® (gepotidacin) Tablets - New Label Expansion – December 11, 2025 – GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application for gepotidacin as an oral option for adult and pediatric patients from 12 years of age weighing at least 45 kg who have limited or no alternative options for the treatment of uncomplicated urogenital gonorrhea caused by susceptible strains of Neisseria gonorrhoeae (e.g., where standard of care is contraindicated, or where patients are intolerant or unwilling to use first line treatment). <Read More> 

Omisirge® (omidubicel-onlv) Suspension for Infusion - New Label Expansion – December 5, 2025 – The U.S. Food and Drug Administration announced it has approved Omisirge® (omidubicel-onlv), the first hematopoietic stem cell transplant (HSCT) therapy to treat patients with severe aplastic anemia (SAA). Omisirge® is indicated for adults and pediatric patients 12 years and older with hematologic malignancies and now is approved for adults and pediatric patients six years and older with SAA following reduced intensity conditioning and for whom a compatible donor is not available.  <Read More> 

Breyanzi® (lisocabtagene maraleucel) Suspension for Intravenous Infusion - New Label Expansion – December 4, 2025 – Bristol Myers Squibb (NYSE: BMY) announced that the U.S. Food and Drug Administration (FDA) has granted approval of Breyanzi® (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy. <Read More> 

Jaypirca® (pirtobrutinib) Tablets - New Label Expansion – December 2, 2025 – The Food and Drug Administration granted traditional approval to pirtobrutinib (Jaypirca®, Eli Lilly and Company) for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor. In 2023, FDA granted accelerated approval to pirtobrutinib for adults with CLL/SLL who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor. <Read More> 

Omlyclo® (omalizumab-igec) Injection - New Label Expansion – December 1, 2025 – Celltrion, Inc. announced the U.S. Food and Drug Administration (FDA) has approved a new presentation of Omlyclo® (omalizumab-igec), the first and only biosimilar designated as interchangeable with Xolair® (omalizumab), in a 300mg/2mL solution in a single-dose prefilled syringe for subcutaneous injection. In the U.S., Omlyclo® will be marketed and distributed exclusively by Celltrion USA, Inc. <Read More> 

Imfinzi® (durvalumab) Injection - New Label Expansion – November 25, 2025 – AstraZeneca’s Imfinzi® (durvalumab) in combination with standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) has been approved in the US for the treatment of adult patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers. The approved regimen includes neoadjuvant Imfinzi in combination with chemotherapy before surgery, followed by adjuvant Imfinzi in combination with chemotherapy, then Imfinzi® monotherapy. <Read More> 

Keytruda® (pembrolizumab) for Injection - New Label Expansion – November 21, 2025 – The Food and Drug Administration approved pembrolizumab (Keytruda®, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex®, Merck) with enfortumab vedotin-ejfv (Padcev®, Astellas Pharma) as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin. <Read More> 

Koselugo® (selumetinib) Capsules and Oral Granules - New Label Expansion – November 19, 2025 – The Food and Drug Administration approved selumetinib (Koselugo®, AstraZeneca Pharmaceuticals LP) for adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). FDA previously approved selumetinib capsules and granules for pediatric patients 1 year of age and older for this indication. <Read More> 

Darzalex Faspro® (daratumumab and hyaluronidase-fihj) Injection - New Label Expansion – November 19, 2025 – The Food and Drug Administration granted traditional approval to daratumumab and hyaluronidase-fihj (Darzalex Faspro®, Janssen Biotech Inc.) with bortezomib, cyclophosphamide, and dexamethasone (VCd) for newly diagnosed light chain (AL) amyloidosis. FDA granted accelerated approval for this indication in 2021. <Read More> 

Eylea HD® (aflibercept) Injection - New Label Expansion – November 19, 2025 – Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the U.S. Food and Drug Administration (FDA) has approved Eylea HD® (aflibercept) Injection 8 mg for the treatment of patients with macular edema following retinal vein occlusion (RVO) with up to every 8-week dosing after an initial monthly dosing period. <Read More> 

Imdelltra™ (tarlatamab-dlle) for Injection - New Label Expansion – November 19, 2025 – The Food and Drug Administration granted traditional approval to tarlatamab-dlle (Imdelltra™, Amgen Inc.) for adults with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. Tarlatamab-dlle received accelerated approval for this indication in 2024. <Read More> 

Epkinly™ (epcoritamab-bysp) Injection - New Label Expansion – November 18, 2025 – The Food and Drug Administration approved epcoritamab-bysp (Epkinly™, Genmab US, Inc.) with lenalidomide and rituximab for relapsed or refractory follicular lymphoma (FL). The FDA also granted traditional approval to epcoritamab-bysp as monotherapy for relapsed or refractory FL after two or more lines of systemic therapy (epcoritamab-bysp was granted accelerated approval for this indication in 2024). <Read More> 

New Drug Shortage

December 10, 2025

December 08, 2025

December 04, 2025

December 03, 2025

December 02, 2025

Updated Drug Shortage

December 17, 2025

December 16, 2025

December 15, 2025

December 12, 2025

December 11, 2025

New Drug Recall and Safety Alerts

No new update.

New Generic/Biosimilar Approval and Launch

Armlupeg™ (pegfilgrastim-unne) Injection - New Neulasta® Biosimilar Approval – November 28, 2025 – Global pharma major Lupin Limited (Lupin), announced that the United States Food and Drug Administration (U.S. FDA) has approved Armlupeg™ (pegfilgrastim-unne) 6 mg/0.6 mL injection for subcutaneous use in a single-dose prefilled syringe, as biosimilar to Neulasta® (pegfilgrastim) 6 mg/0.6 mL injection. The product will be manufactured at Lupin’s Biotech facility in Pune, which was inspected by the U.S. FDA prior to approval. <Read More> 

Clinical and Pharmacy News

More Than 6,000 Medical Errors Every Year – December 18, 2025 - More than 20,000 cases of adverse medical events have been reported in our country over the past eight years, while more than 1,000 cases have reached the courts and received final rulings. The majority of these rulings vindicate those who filed claims after a medical error caused significant physical or psychological harm to themselves or their loved ones — and in some cases, the error even led to death. <Read More> 

Combination Pills for High Blood Pressure May Simplify Treatment, Improve Long-Term Health – December 15, 2025 – Taking one pill that combines two or more blood pressure medications may help adults with high blood pressure (also known as hypertension) lower their blood pressure level faster and more effectively than taking multiple medications separately, and it may also reduce the risk of heart attack and stroke, according to a new scientific statement published in the American Heart Association’s journal Hypertension. <Read More> 

Caring for Patients with Monkeypox – December 12, 2025 – Regardless of clade, monkeypox can be spread, treated, and prevented the same way. Most monkeypox patients without severe immunocompromise will recover with supportive care and pain control only. CDC's interim clinical guidance may assist clinicians in managing patients who have or are at risk for severe manifestations of monkeypox. There are no FDA-approved treatments specifically for monkeypox, but there are FDA-regulated medications that may help. <Read More> 

New Guidelines Recommend Nerve Blocks for Migraine ER Treatment – December 11, 2025 – People hospitalized for a debilitating migraine should receive targeted nerve blocks rather than IV opioids to quell their pain, a major update of treatment guidelines suggests. Doctors should use a nerve block injection to stop pain signals from thrumming through the occipital nerves located near the top of the spine, a report published in Headache: The Journal of Head and Face Pain, said. <Read More> 

Pharmacy and PBM Enforcement Trends: False Claims Act Risks in 2025 – December 11, 2025 – Pharmacy benefit managers (PBMs) manage prescription coverage for health plans and big employers. They decide which medicines are covered and at what price, negotiate discounts with drug makers, and set prices for pharmacies…Taken together, these matters demonstrate a renewed focus on pharmacy-related fraud. And while the financial recoveries differ dramatically, from hundreds of millions against national chains to a six-figure settlement against a small, independent pharmacy, the message is the same: Pharmacies and PBMs sit squarely in the DOJ’s enforcement sights. <Read More> 

ISMP Announces New Medication Safety Best Practices – December 11, 2025 – Improving safety with IV push medications, optimizing use of scanning machine-readable codes on patient identification bands and products, and improving the culture of safety are three new Targeted Medication Safety Best Practices suggested by the Institute for Safe Medication Practices (ISMP) for 2026-2027. These add to the 22 Best Practices suggested for 2024-2025, said Christina Michalek, RPh, FASHP, the director of membership and patient safety organization at ISMP, during a presentation at the ASHP Midyear 2025 Clinical Meeting & Exhibition, in Las Vegas. ISMP also updated two existing Best Practices: to add patient weights in electronic prescriptions and discharge and after-visit summaries, and to enhance medication reconciliation policies at hospital admission during transitions of care and at discharge. <Read More> 

FDA Warns Consumers Not to Use Counterfeit Ozempic® (Semaglutide) Found in U.S. Drug Supply Chain – December 5, 2025 – FDA recently seized dozens of units of counterfeit Ozempic® (semaglutide) injection 1 mg that were distributed illegally outside of Novo Nordisk's authorized supply chain. The seized counterfeit products were in the legitimate U.S. drug supply chain. The counterfeit products are labeled with lot number - PAR1229 - which also is an authentic lot number. <Read More> 

340B in the News

A New Call for 340B Transparency, Reform – December 12, 2025 – In a hearing that was at once contentious and unusually bipartisan, members of the Senate Health, Education, Labor and Pensions (HELP) Committee called for stronger oversight of the federal 340B Drug Discount Program while emphasizing its continued importance to safety-net hospitals and clinics. Witnesses from the Government Accountability Office (GAO), the Congressional Budget Office (CBO), and academic medicine testified on Oct. 23 that the program, intended to help hospitals stretch scarce financial resources, has grown exponentially while oversight has not kept pace. Senators from both parties urged reform but warned against changes that could undermine access to care for rural and underserved populations. <Read More> 

340B Discounts at Risk in 2025 and Beyond – December 12, 2025 – The 340B Drug Pricing Program faces intensifying scrutiny and legal battles at both state and federal levels in 2025. Pharmacy benefit managers (PBMs) are tightening point-of-sale claim identification, states are enacting anti-discrimination protections, and covered entities are waiting for the next shoe to drop. “Depending on who you’re speaking with, 340B is either the greatest thing since sliced bread—or Lord Voldemort himself,” said Jesse Dresser, Esq, a partner in Frier Levitt’s Life Sciences Department who heads the firm’s pharmacy practice group. <Read More> 

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Ready to get started?

The Pillr Health team is here to empower your 340B program, and beyond. Reach out at the link below.

Contact Us