Clinical Insights: April 16th, 2026
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
Foundayo™ (orforglipron) Tablets – New Drug Approval – April 1, 2026 - Eli Lilly and Company (NYSE: LLY) announced the U.S. Food and Drug Administration (FDA) approved Foundayo™ (orforglipron) for adults with obesity, or overweight with weight-related medical problems. When used alongside a reduced-calorie diet and increased physical activity, Foundayo™ helps individuals lose excess body weight and keep the weight off. Foundayo™ will be available via LillyDirect®, with prescriptions accepted immediately and shipping beginning April 6, followed shortly after by broad availability through U.S. retail pharmacies and telehealth providers. <Read More>
Awiqli® (insulin icodec-abae) Injection – New Drug Approval – March 26, 2026 - Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved Awiqli® (insulin icodec-abae) injection 700 units/mL, the first and only once-weekly, long-acting basal insulin, indicated as an adjunct to diet and exercise to improve glycaemic control (blood sugar) in adults living with type 2 diabetes. The approval offers the only once‑weekly basal insulin option, providing a new treatment solution that fits different patient routines and preferences for adults living with type 2 diabetes. <Read More>
Kresladi™ (marnetegragene autotemcel) Suspension for Intravenous Infusion – New Drug Approval – March 26, 2026 - The U.S. Food and Drug Administration approved Kresladi™ (marnetegragene autotemcel), the first gene therapy for the treatment of severe Leukocyte Adhesion Deficiency Type I (LAD-I). Kresladi™ is indicated for the treatment of pediatric patients with severe leukocyte adhesion deficiency I (LAD-I) due to biallelic variants in ITGB2 without an available human leukocyte antigen (HLA)-matched sibling donor for allogeneic hematopoietic stem cell transplant. <Read More>
Lifyorli™ (relacorilant) Capsules – New Drug Approval – March 25, 2026 - The Food and Drug Administration approved relacorilant (Lifyorli™, Corcept Therapeutics Inc.), a glucocorticoid receptor antagonist, in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab. <Read More>
Avlayah™ (tividenofusp alfa-eknm) Lyophilized Powder for Injection – New Drug Approval – March 24, 2026 - Denali Therapeutics Inc. (Nasdaq: DNLI) announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Avlayah™ (tividenofusp alfa-eknm), the first FDA-approved biologic specifically designed to cross the blood-brain barrier and reach the whole body, including the brain. Avlayah™ is an enzyme replacement therapy indicated for the treatment of neurologic manifestations of Hunter syndrome (mucopolysaccharidosis type II, or MPS II) when initiated in presymptomatic or symptomatic pediatric patients weighing at least 5 kg prior to advanced neurologic impairment. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial. <Read More>
Lynavoy™ (linerixibat) Tablets – New Drug Approval – March 17, 2026 - GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has approved Lynavoy™ (linerixibat) for the treatment of cholestatic pruritus in adult patients with PBC. Lynavoy™, an ileal bile acid transporter (IBAT) inhibitor that reduces multiple drivers of chronic itch, is the first medicine approved in the US for this indication. <Read More>
Icotyde™ (icotrokinra hydrochloride) Tablets – New Drug Approval – March 17, 2026 - Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) has approved Icotyde™ (icotrokinra), an interleukin-23 (IL-23) receptor antagonist for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy. Icotyde™ is the first and only targeted oral peptide that precisely blocks the IL-23 receptor. <Read More>
Yuviwel® (navepegritide) Lyophilized Powder for Injection - formerly TransCon CNP – New Drug Approval – February 27, 2026 - Ascendis Pharma A/S (Nasdaq: ASND) announced that the U.S. Food & Drug Administration (FDA) has granted approval under the FDA’s Accelerated Approval Program for Yuviwel® (navepegritide; developed as TransCon® CNP), the first and only once-weekly treatment indicated to increase linear growth in children 2 years of age and older with achondroplasia with open epiphyses and the only one to provide continuous systemic exposure to CNP over the weekly dosing interval. Continued approval for this indication, which was based on an improvement in annualized growth velocity (AGV), may be contingent upon verification and description of clinical benefit in confirmatory trial(s). <Read More>
Desmoda™ (desmopressin acetate) Oral Solution - formerly ET-600 – New Drug Approval – February 25, 2026 - Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, announced the U.S. Food and Drug Administration (FDA) approval of a New Drug Application (NDA) for Desmoda™ (desmopressin acetate) Oral Solution for the management of central diabetes insipidus, also known as arginine vasopressin deficiency (AVP-D), as antidiuretic replacement therapy for patients of all ages. <Read More>
Loargys® (pegzilarginase-nbln) Injection – New Drug Approval – February 23, 2026 - Immedica Pharma announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Loargys® (pegzilarginase-nbln), an arginine specific enzyme indicated for the treatment of hyperargininemia in adult and pediatric patients 2 years of age and older with Arginase 1 Deficiency (ARG1-D), in conjunction with dietary protein restriction. <Read More>
Bysanti™ (milsaperidone) Tablets – New Drug Approval – February 20, 2026 - Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) announced that the U.S. Food and Drug Administration (FDA) has approved Bysanti™ (milsaperidone) tablets, a first line therapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for the treatment of schizophrenia in adults. <Read More>
New Label Expansions
Eylea HD® (aflibercept) Injection – New Label Expansion – New Dosage Regimen: April 2, 2026 – Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the U.S. Food and Drug Administration (FDA) has approved the extension of dosing intervals for Eylea HD® (aflibercept) up to every 20 weeks for patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME) following one year of successful response based on visual and anatomic outcomes. As part of the approval, the FDA has updated the Eylea HD® label to include 96-week (2-year) data from the pivotal PULSAR trial in wAMD and the pivotal PHOTON trial in DME, demonstrating sustained efficacy and safety through 2 years with extended dosing intervals. <Read More>
Tecartus® (brexucabtagene autoleucel) Suspension for Intravenous Infusion – New Label Expansion – Labeling Revision Approved: April 1, 2026 - The U.S. Food and Drug Administration (FDA) has granted traditional (full) approval to Kite’s CAR T-cell therapy, Tecartus® (brexucabtagene autoleucel), for adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL). The full approval now includes efficacy, safety and pharmacokinetic data from Cohort 3 of the ZUMA-2 study in patients who are R/R after one or more lines of therapy and who are Bruton tyrosine kinase inhibitor (BTKi)-naïve. <Read More>
Spinraza® (nusinersen) Injection – New Label Expansion – New Dosage Regimen: March 27, 2026 - Biogen Inc. (Nasdaq: BIIB) announced that the High Dose Regimen of Spinraza® (nusinersen), which is comprised of 50 mg/5 mL and 28 mg/5 mL doses, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of spinal muscular atrophy (SMA). Backed by more than 10 years of clinical data supporting the Low Dose Regimen of Spinraza® (12 mg), High Dose Spinraza® was designed to deliver a higher concentration of drug through both the loading and maintenance dosing phases, to provide a new option in response to the ongoing needs of the community. <Read More>
Alyftrek® (deutivacaftor, tezacaftor and vanzacaftor) – New Label Expansion – Labeling Revision Approved: March 27, 2026 - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced the U.S. Food and Drug Administration (FDA) has approved expanded use of Alyftrek® (vanzacaftor/tezacaftor/deutivacaftor) for the treatment of people with cystic fibrosis (CF) ages 6 and older with a variant in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is either responsive based on clinical and/or in vitro data or results in production of CFTR protein. Additionally, the U.S. FDA has also expanded the indication statement for Trikafta® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in patients ages 2 and older. <Read More>
neffy® (epinephrine) Nasal Spray – New Label Expansion – Labeling Revision Approved: March 26, 2026 - ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from allergic reactions that could lead to anaphylaxis, announced that the U.S. Food and Drug Administration (FDA) has approved updating the neffy® 1 mg (epinephrine nasal spray) prescribing information to remove the age criteria so all children and adults who weigh 33 lbs. or more can utilize neffy® for the emergency treatment of Type 1 allergic reactions, including anaphylaxis. Prior to the update, pediatric patients needed to meet a weight requirement and be at least four years of age. <Read More>
Adstiladrin® (nadofaragene firadenovec-vncg) Suspension for Intravesical Use – New Label Expansion – Labeling Revision Approved: March 23, 2026 - Ferring Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved a label update for Adstiladrin® (nadofaragene firadenovec-vncg), enabling an accelerated water-bath thawing method, completed in about 25 minutes, to enhance efficient clinical preparation for healthcare teams. <Read More>
Opdivo® (nivolumab) Injection – New Label Expansion – New Indication Approved: March 20, 2026 - Bristol Myers Squibb (NYSE: BMY) announced that Opdivo® (nivolumab) has received approval for two new classical Hodgkin Lymphoma (cHL) indications in the U.S. and the European Union (EU). The U.S. Food and Drug Administration (FDA) granted approval of Opdivo® in combination with doxorubicin, vinblastine and dacarbazine (AVD) for the treatment of adult and pediatric patients 12 years and older with previously untreated, Stage III or IV cHL. <Read More>
Imcivree® (setmelanotide) Injection – New Label Expansion – New Indication Approved: March 19, 2026 - Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s supplemental New Drug Application (sNDA) for Imcivreeâ (setmelanotide) seeking approval for the treatment of conditions associated with acquired hypothalamic obesity. <Read More>
Wegovy® (semaglutide) Injection and Tablets – New Label Expansion – New Dosage Form Approved: March 19, 2026 - The U.S. Food and Drug Administration approved a new higher dose (7.2 mg) of Wegovy® (semaglutide) injection, called Wegovy® HD, for weight loss and long-term maintenance of weight loss for certain adult patients. The decision was granted just 54 days after filing and represented the fourth approval under the Commissioner’s National Priority Voucher (CNPV) pilot program. <Read More>
Cosentyx® (secukinumab) Injection – New Label Expansion – Patient Population Altered: March 13, 2026 - Novartis announced that Cosentyx® (secukinumab) received US Food and Drug Administration (FDA) approval for treating pediatric patients 12 years and older with moderate to severe hidradenitis suppurativa (HS), making it the only IL-17A inhibitor for this population. The approval of a distinct biologic option for pediatric patients living with HS allows treatment to be tailored to the individual and establishes Cosentyx® as a meaningful addition to the treatment landscape. <Read More>
Arexvy™ (respiratory syncytial virus vaccine, adjuvanted) Suspension for Intramuscular Injection – New Label Expansion – Patient Population Altered: March 12, 2026 - GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has expanded the approved age indication of Arexvy™ (Respiratory Syncytial Virus Vaccine, Adjuvanted) to adults aged 18 to 49 years at increased risk for lower respiratory tract disease (LRTD) caused by RSV. Arexvy™ was previously approved in the US for the prevention of RSV-related LRTD in adults aged 60 and older, and adults aged 50–59 at increased risk for LRTD caused by RSV. This vaccine is not for use in pregnant individuals. <Read More>
Wellcovorin™ (leucovorin calcium) Tablets – New Label Expansion – New Indication Approved: March 9, 2026 - The U.S. Food and Drug Administration approved expanded use of Wellcovorin™ (leucovorin calcium) tablets for the treatment of cerebral folate deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (CFD-FOLR1). <Read More>
Pylarify™ (piflufolastat F 18) Injection – New Label Expansion – New Formulation Approved: March 6, 2026 - Lantheus Holdings, Inc. (“Lantheus”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, announced that the U.S. Food and Drug Administration (FDA) has approved Pylarify TruVu™ (piflufolastat F 18) injection, a new formulation of its F 18 prostate-specific membrane antigen (PSMA) imaging agent. Pylarify TruVu™ is indicated for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. <Read More>
Sotyktu® (deucravacitinib) Tablets – New Label Expansion – New Indication Approved: March 6, 2026 - Bristol Myers Squibb (NYSE:BMY) announced that the U.S. Food and Drug Administration (FDA) has approved Sotyktu® (deucravacitinib) for the treatment of adults with active psoriatic arthritis (PsA). Sotyktu®, an oral, selective tyrosine kinase 2 (TYK2) inhibitor, is the first TYK2 inhibitor to be approved for PsA. <Read More>
Tecvayli® (teclistamab-cqyv) Injection – New Label Expansion – New Indication Approved: March 5, 2026 - Johnson & Johnson (NYSE:JNJ), a worldwide leader in multiple myeloma therapies, announced that the U.S. Food and Drug Administration (FDA) approved Tecvayli® (teclistamab-cqyv) plus Darzalex Faspro® (daratumumab and hyaluronidase-fihj) for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent. <Read More>
Palynziq® (pegvaliase-pqpz) Injection – New Label Expansion – Patient Population Altered: February 27, 2026 - BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental Biologics License Application (sBLA) for Palynziq® (pegvaliase-pqpz) to include pediatric patients 12 years of age and older with phenylketonuria (PKU). Palynziq® is the only enzyme substitution therapy approved to reduce blood phenylalanine (Phe) concentrations in people with PKU. <Read More>
Sogroya® (somapacitan-beco) Injection – New Label Expansion – Patient Population Altered: February 27, 2026 - Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved three new indications for once-weekly Sogroya® (somapacitan-beco) injection 5 mg, 10 mg, or 15 mg, a long-acting growth hormone. Sogroya® is now indicated for children aged 2.5 years and older with Idiopathic Short Stature (ISS), short stature born Small for Gestational Age (SGA) and with no catch-up growth by 2 years of age, or growth failure associated with Noonan Syndrome (NS). Sogroya® is also indicated for children aged 2.5 years and older and adults with growth hormone deficiency (GHD). <Read More>
Hernexeos® (zongertinib) Tablets – New Label Expansion – New Indication Approved: February 26, 2026 - The U.S. Food and Drug Administration (FDA) approved Boehringer Ingelheim’s Hernexeos® (zongertinib tablets) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test. This indication is approved under accelerated approval based on objective response rate and duration of response. <Read More>
Juxtapid® (lomitapide) Capsules – New Label Expansion – Patient Population Altered: February 25, 2026 - Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases, announced that the U.S. Food and Drug Administration (FDA) has approved Juxtapid® (lomitapide) capsules for pediatric use in homozygous familial hypercholesterolemia (HoFH) for children 2 years of age and older. Juxtapid® is a proven therapy that has been approved in the United States for adult patients with HoFH to be used along with diet and other lipid-lowering treatments, since 2012. <Read More>
Braftovi® (encorafenib) Capsules – New Label Expansion – New Indication Approved: February 24, 2026 - Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has granted full approval to Braftovi® (encorafenib) in combination with cetuximab (marketed as Erbitux®) and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation based on results from the global Phase 3 BREAKWATER trial. <Read More>
Dupixent® (dupilumab) Injection – New Label Expansion – New Indication Approved: February 23, 2026 - The US Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for the treatment of adult and pediatric patients aged 6 years and older with allergic fungal rhinosinusitis (AFRS) who have a history of sino-nasal surgery. The FDA evaluated Dupixent® under priority review for the treatment of AFRS, which is reserved for medicines that have the potential to provide significant improvements in the treatment, diagnosis, or prevention of serious conditions. This approval expands our approved indications in sino-nasal diseases to now include AFRS, alongside chronic rhinosinusitis with nasal polyps. <Read More>
Elucirem™ (gadopiclenol) Injection – New Label Expansion – Patient Population Altered: February 20, 2026 - Guerbet, a global specialist in contrast media and solutions for medical imaging, is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved a labeling update for Elucirem™ (gadopiclenol) injection. The new indication includes approval for pediatric patients aged 0-2 years (including term neonates) for its macrocyclic high-relaxivity gadolinium-based contrast agent. <Read More>
Calquence® (acalabrutinib) Capsules and Tablets – New Label Expansion – New Indication Approved: February 19, 2026 - AstraZeneca’s Calquence® (acalabrutinib) in combination with venetoclax has been approved in the US as the first all-oral, fixed-duration regimen for the treatment of adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The approval by the US Food and Drug Administration (FDA) was based on positive results from the AMPLIFY Phase III trial, which were presented at the American Society of Hematology 2024 Annual Meeting and published in The New England Journal of Medicine. <Read More>
Wakix® (pitolisant) Tablets – New Label Expansion – Patient Population Altered: February 13, 2026 - Harmony Biosciences (Nasdaq: HRMY) announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) for Wakix® (pitolisant) tablets for the treatment of cataplexy in pediatric patients 6 years of age and older with narcolepsy. Wakix® is now the first-and-only FDA-approved non-scheduled treatment for pediatric and adult narcolepsy patients with or without cataplexy. <Read More>
Rybrevant Faspro™ (amivantamab and hyaluronidase-lpuj) Injection – New Label Expansion – New Dosage Regimen: February 13, 2026 - Johnson & Johnson (NYSE: JNJ) announced the U.S. Food and Drug Administration (FDA) has approved a new, simplified monthly dosing schedule for Rybrevant Faspro™ (amivantamab and hyaluronidase-lpuj). When administered in combination with oral Lazcluze® (lazertinib) for the first-line treatment of epidermal growth factor receptor (EGFR)-mutated advanced non-small cell lung cancer (NSCLC), monthly dosing delivers consistent outcomes with the previously approved bi-weekly subcutaneous (SC) dosing schedule. <Read More>
Enzeevu® (aflibercept-abzv) Injection – New Label Expansion – New Indication Approved: February 12, 2026 - Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in affordable medicines, announced that the US Food and Drug Administration (FDA) has approved an expanded label for Enzeevu® (aflibercept-abzv), to include multiple retinal indications. <Read More>
Keytruda® (pembrolizumab) for Injection – New Label Expansion – New Indication Approved: February 10, 2026 - Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced the U.S. Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab) and Keytruda QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) plus paclitaxel, with or without bevacizumab, for the treatment of adults with PD-L1+ (Combined Positive Score [CPS] ≥1), as determined by an FDA-authorized test, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma, who have received one or two prior systemic treatment regimens. <Read More>
Yescarta® (axicabtagene ciloleucel) Suspension for Intravenous Infusion – New Label Expansion – Labeling Revision Approved: February 5, 2026 - Kite, a Gilead Company (Nasdaq: GILD), announced the U.S. Food and Drug Administration (FDA) approved an update to the Yescarta® (axicabtagene ciloleucel) prescribing information removing the previous Limitations of Use in patients with relapsed or refractory (R/R) primary central nervous system lymphoma (PCNSL).
Ozempic® (semaglutide) Injection and Tablets – New Label Expansion – Labeling Revision Approved: January 30, 2026 – Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved Ozempic® (semaglutide) tablets 1.5 mg, 4 mg, and 9 mg as the name for oral semaglutide 1.5 mg, 4 mg, and 9 mg. The active ingredient remains the same semaglutide molecule, and the Ozempic® pill is FDA-approved for use in adults with type 2 diabetes to improve blood sugar along with diet and exercise, and to reduce the risk of major adverse cardiovascular events (CV death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes who are at high risk for these events. <Read More>
New Drug Shortage
April 10, 2026
Nitrofurantoin Oral Suspension (Discontinuation)
April 09, 2026
Azithromycin Tablet (Discontinuation)
April 08, 2026
Aprepitant Oral Powder for Suspension (Discontinuation)
Fosaprepitant Dimeglumine Injection (Discontinuation)
April 07, 2026
Idelalisib Tablet (Discontinuation)
April 06, 2026
Ursodiol Capsule (Discontinuation)
Updated Drug Shortage
April 10, 2026
Carboplatin Injection (Currently in Shortage)
Dobutamine Hydrochloride Injection (Currently in Shortage)
Hydromorphone Hydrochloride Injection (Currently in Shortage)
Meperidine Hydrochloride Injection (Currently in Shortage)
April 09, 2026
Lisdexamfetamine Dimesylate Capsule (Currently in Shortage)
Lisdexamfetamine Dimesylate Tablet, Chewable (Currently in Shortage)
Methylphenidate Hydrochloride Tablet, Extended Release (Currently in Shortage)
Technetium TC-99M Pyrophosphate Kit Injection (Currently in Shortage)
April 08, 2026
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet (Currently in Shortage)
Azacitidine Injection (Currently in Shortage)
Bumetanide Injection (Currently in Shortage)
Bupivacaine Hydrochloride Injection (Currently in Shortage)
Carboplatin Injection (Currently in Shortage)
Dexamethasone Sodium Phosphate Injection (Currently in Shortage)
Dexmedetomidine Hydrochloride Injection (Currently in Shortage)
Furosemide Injection (Currently in Shortage)
Lidocaine Hydrochloride Injection (Currently in Shortage)
Methylprednisolone Acetate Injection (Currently in Shortage)
Rocuronium Bromide Injection (Currently in Shortage)
Ropivacaine Hydrochloride Injection (Currently in Shortage)
April 07, 2026
Clindamycin Phosphate Injection (Currently in Shortage)
Heparin Sodium Injection (Currently in Shortage)
April 06, 2026
Bumetanide Injection (Currently in Shortage)
Furosemide Injection (Currently in Shortage)
Rocuronium Bromide Injection (Currently in Shortage)
Sterile Water Irrigant (Currently in Shortage)
New Drug Recall and Safety Alerts
Wound Care Gel Products by Blaine Labs, Inc - New Voluntary Recall – April 8, 2026 - Blaine Labs, Inc. is voluntarily recalling three (3) lot numbers of Wound Care Gel products, 1 oz. & 3 oz. (0.1% Benzalkonium Chloride) to the consumer level due to microbial contamination. The affected product has been found to contain Lysinibacillus fusiformis, an environmental organism. <Read More>
Magnesium Sulfate in Water for Injection, USP 4 g/100mL (NDC 70121-1720-3) by Amneal Pharmaceuticals LLC – New Voluntary Recall – March 24, 2026 - Amneal Pharmaceuticals LLC is voluntarily recalling one lot of Magnesium Sulfate in Water for Injection, USP, 4g/100mL, IV bag, to the hospital level. A Magnesium Sulfate in Water for Injection pouch was found to contain an IV bag of Tranexamic Acid in 0.7% Sodium Chloride Injection, 10 mg/mL. <Read More>
Webcol™ Large Alcohol Prep Pad by Cardinal Health – New Voluntary Recall – March 19, 2026 - Cardinal Health has issued a voluntary recall for select lots of Webcol™ Large Alcohol Prep Pads (70% isopropyl alcohol) to the consumer level. The product is being recalled due to microbial contamination identified as Paenibacillus phoenicis. <Read More>
New Generic/Biosimilar Approval and Launch
Ponlimsi™ (denosumab-adet) Injection – New Prolia® Biosimilar Approval – March 27, 2026 - Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced milestones in its biosimilar portfolio, demonstrating continued momentum in the advancement of its Pivot to Growth strategy. The United States (U.S.) Food and Drug Administration (FDA) has approved Ponlimsiä (denosumab-adet) as a biosimilar to Prolia®. <Read More>
Clinical and Pharmacy News
Questioning the Prescription: Antidepressants and the Medicalization of Childhood – April 10, 2026 – This week Mad in America explores four recently published articles related to antidepressant use in children and adolescents. The first reports that although clinical trials have found little efficacy for the use of fluoxetine (Prozac®) as a treatment for depression in children, clinical guidelines still recommend it. The second finds that persistent antidepressant use is common and rising in Australian children… <Read More>
Under the Magnifying Glass: A Wave of Drug Price Transparency – April 1, 2026 - In the span of a single week in late January and early February 2026, 3 federal actions—by Congress, the Department of Labor (DOL), and the Federal Trade Commission (FTC)—brought transparency efforts to the forefront of drug pricing policy. Whereas recent reforms have centered on prices set by pharmaceutical companies, this new wave of provisions shifts the focus to the role of pharmacy benefit managers (PBMs). <Read More>
How Hospital Pharmacies Can Access Restrictive Specialty Networks – March 2, 2026 - As payors and pharmacy benefit managers (PBMs) narrow specialty pharmacy networks, health system pharmacies face increasing exclusion from dispensing high-cost therapies to their own patients. For many organizations, accessing these restrictive networks has become both a strategic imperative and an operational challenge. Signature Healthcare, a regional health system in southern Massachusetts, addressed this challenge by partnering with Clearway Health, a specialty pharmacy services organization that originated from Boston Medical Center Health System. Clearway Health now collaborates with hospitals nationwide to improve access to care for patients requiring complex, high-cost medications. <Read More>
As Rare Disease Drug Approvals Accelerate, Survey Highlights Gaps in Care Coordination – March 2, 2026 - As the pipeline for rare disease therapies continues to expand, new survey data suggest that the healthcare system is not keeping pace with the coordination demands required to deliver those treatments effectively. A national survey commissioned by PANTHERx Rare and conducted by Morning Consult found that patients, caregivers, and healthcare professionals perceive wide gaps in rare disease care delivery, whereas payors view care coordination far more favorably. Among patients and caregivers, 76% rated the current rare disease care system as average, below average, or poor, with 44% describing it as poor. Healthcare professionals were even more critical: 86% rated the system as average or worse, and 50% described it as poor. In contrast, a majority of payors (58%) rated the system as good, revealing what the report describes as a stakeholder disconnect. <Read More>
Pharmacist Welcomes Bill Restricting Pharmacy Benefit Managers; CVS Projects Mass Closures – February 25, 2026 - Tennessee’s Senate Health and Welfare Committee considered a bill to place restrictions on pharmacy benefit managers (PBMs) on Wednesday. According to the American Medical Association, a pharmacy benefit manager is a middleman in the prescription drug supply chain. They manage prescription drug plan benefits for insurers and employers. PBMs negotiate rebates and discounts, put together networks, and conduct management tasks. Sen. Bobby Harshbarger (R-Kingsport), a pharmacist himself, proposed the bill known as the Fair Rx Act. Christian Tate, a pharmacist at Berry’s Pharmacy in Kingsport, said independent pharmacists just want an equal playing field, and the bill would be a step in the right direction. <Read More>
Bridging the Gap in Biosimilar Use and Uptake in Inflammatory Conditions – February 24, 2026 - Within the last 5 years, the FDA has approved several key biosimilars for inflammatory conditions such as inflammatory bowel disease and rheumatologic disorders. Infliximab biosimilars entered the market in 2016 as IV infusions only and are billed through the medical benefit. In 2023 and 2025, adalimumab and ustekinumab biosimilars were approved, respectively. Adalimumab has 10 biosimilars, and ustekinumab has 7 on the market. Given that self-administered adalimumab and ustekinumab are billed through the pharmacy benefit, they introduce a new set of challenges and opportunities. This article addresses barriers that arise for the prescribing provider and team, including specialty pharmacists who manage biologic access in collaboration with the clinic, and provides recommendations for future biosimilar utilization. <Read More>
ACC, AHA Release First-Ever Guideline for Treatment and Management of Acute PE – February 19, 2026 - The new “ACC/AHA Guideline for the Evaluation and Management of Acute Pulmonary Embolism (PE) in Adults” is a de novo document offering comprehensive, evidence‑based recommendations for the evaluation, management and follow‑up of adults with acute PE. Collaborated on and endorsed by an additional eight societies, the new guideline recognizes that management of patients with acute PE "is uniquely multidisciplinary and crosses emergency department, inpatient settings and outpatient clinics." <Read More>
House Members Push for PBM Changes, Question Trump Drug Plan – February 11, 2026 - Lawmakers from both sides of the aisle on Wednesday came down hard on various sectors of the U.S. prescription drug supply chain during a hearing to shed light on the reasons for rising costs. At a House Energy and Commerce Health Subcommittee hearing, Rep. Brett Guthrie, R-Ky., touted changes in the fiscal 2026 spending package enacted this month to improve pharmacy-benefit manager pricing transparency and reduce incentives for PBMs to promote higher-priced drugs to Medicare Part D beneficiaries. But Guthrie stressed that further changes could be forthcoming. “Historic PBM reform is just the beginning,” said Guthrie, who chairs the full Energy and Commerce panel. “More needs to be done throughout the drug supply chain to improve affordability.” <Read More>
340B in the News
AbbVie Challenges 'Outdated' 340B Drug Discount Program Guidance in New Lawsuit – April 9, 2026 - AbbVie is spearheading a new battle in pharma’s long-running fight to reform the federal government’s 340B drug discount program with a lawsuit that challenges the definition of what it means to be a “patient” under the program's framework. AbbVie, a three-decade participant in the 340B system, leveled the suit to “restore integrity” to the drug discount program, the company explained in its 72-page complaint against the Department of Health and Human Services (HHS) and its secretary Robert F. Kennedy Jr., plus the Department of Health Resources and Services Administration (HRSA) and administrator Thomas Engels. <Read More>
Updates to 340B and What Pharmacists Need to Know – March 26, 2026 - The 340B Drug Pricing Program is a federally mandated drug pricing program created by Congress in 1992 that allows certain health care organizations (called covered entities) to purchase specific outpatient drugs at significantly discounted prices. The core intent is to help these providers “stretch scarce resources” so they can serve low-income and underserved patients, reach more patients, and provide more comprehensive services in their communities. However, despite its original intent, the program faces various challenges in the shape of manufacturer restrictions, legal and regulatory uncertainty, administrative burdens, and compliance risks. As restrictions, litigation, and reimbursement cuts stack up, 340B savings shrink. <Read More>
Association Between 340B Contract Pharmacy Growth and Payer-Specific Drug Coverage – February 27, 2026 - The 340B Drug Pricing Program entitles participating hospitals and clinics (called covered entities) to purchase outpatient drugs at a substantial discount from manufacturers. Covered entities either distribute 340B drugs at reduced prices to patients or generate a subsidy by charging insured patients market prices for discounted drugs. Drugs purchased through 340B accounted for $66 billion in 2023, with approximately one-fifth of this sum coming from sales through unaffiliated community retail pharmacies, called contract pharmacies. We linked data on contract pharmacy locations to Managed Market Surveyor data to describe the markets in which 340B covered entities locate contract pharmacies. <Read More>
Report Questions Drug Pricing as Supporters Defend 340B Program – February 19, 2026 - Hospitals and clinics in Michigan participating in a federal drug discount program are marking up medications and shifting costs onto public employee health plans, according to a new analysis. The report from IQVIA, a health data analytics and research company, found that providers participating in the federal 340B Drug Pricing Program are buying medications at steep discounts and billing insurers at much higher rates – increasing costs for both state health plans and taxpayers. <Read More>
Trump Administration Restarts its Efforts to Pilot 340B Rebates – February 13, 2026 – Only a week after calling it quits on a court-halted pilot program, the Trump administration is already revving the engine on how it could test out a rebate model for the 340B Drug Discount program. The Health Resources and Services Administration (HRSA) released a request for information (RFI) asking stakeholders and the public for input on whether and how such a model should be implemented for 340B, which, for over 30 years, has required drug manufacturers to provide upfront discounts on their products to help subsidize safety-net care. <Read More>
Following Legal Setbacks, HHS Agrees to Toss 340B Rebate Model Pilot Program – February 6, 2026 - The Department of Health and Human Services has officially backed down on its halted 340B Rebate Model Pilot Program, telling the courts this week that it plans to pull relevant notices and application approvals. Lawyers for the government and plaintiffs who sued to block the program—several hospitals and hospital groups including American Hospital Association (AHA)—filed Thursday afternoon in the U.S. District Court for the District of Maine a joint motion for vacatur and remand. <Read More>
Site-of-Care Shift for Physician-Administered Drug Therapies: 2026 Update – January 2026 - Using new Medicare data, this paper updates a prior analysis1 evaluating the site of care for all Medicare Part B drug therapies and finds that previously observed trends are continuing. Specifically, 340B Drug Pricing Program hospital outpatient departments (HOPDs)—including both HOPDs at the hospital itself and off-campus locations—continue to represent a growing share of outpatient drug administrations. This analysis also examines how these trends are reflected in top drugs used to treat breast cancer, rheumatoid arthritis, and multiple myeloma. <Read More>
