Drugs

RAHWAY, N.J.–(BUSINESS WIRE) April 3, 2023 — Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC)

fruquintinib Treatment for Colorectal Cancer HUTCHMED Completes Rolling Submission of NDA to U.S. FDA for Fruquintinib for the Treatment of Refractory Metastatic Colorectal Cancer Hong Kong, Shanghai & Florham Park, NJ — Friday March 31, 2023: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM, HKEX:​13) today announces that it completed the rolling submission of a New Drug Application

RAHWAY, N.J.–(BUSINESS WIRE) March 29, 2023 — Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has granted full approval to Keytruda, Merck’s anti-PD-1 therapy, for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or

March 31, 2023 Audience: Health Professional, Pharmacy, Consumer March 31, 2023 – Piscataway, NJ, Camber Pharmaceuticals, Inc. is voluntarily recalling lot # E220182 of Atovaquone Oral Suspension, USP 750mg/5mL to the Consumer/User level, due to the potential Bacillus cereus contamination in the product. Risk Statement: In the population most at risk, immunocompromised population, there is

GAITHERSBURG, Md., March 29, 2023 (GLOBE NEWSWIRE) — Today, Emergent BioSolutions Inc. (NYSE: EBS) announced that the U.S. Food and Drug Administration (FDA) has approved Narcan® Naloxone HCl Nasal Spray 4 mg as an over-the-counter (OTC) emergency treatment of opioid overdose. This decision comes at a time when approximately every eight minutes, a person dies

Biosimilar Hyrimoz® (adalimumab-adaz) high-concentration formulation (HCF) approved for seven indications of reference medicine Humira®* With this approval, Sandoz adalimumab HCF biosimilar will offer US patients reduced injection volume in citrate-free formulation Sandoz continues to expand patient access to much-needed medications, increase healthcare savings and fuel innovation through increased competition Basel, March 21, 2023 – Sandoz,

FDA Approves Joenja (leniolisib) for the Treatment of Activated Phosphoinositide 3-Kinase Delta Syndrome (APDS) LEIDEN, The Netherlands, March 24, 2023 /PRNewswire/ — Pharming Group N.V. (“Pharming” or “the Company”) (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) announces that the US Food and Drug Administration (FDA) has approved Joenja® (leniolisib) for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ)

March 22, 2023 Audience: Health Professional, Pharmacy, Consumer March 22, 2023 – Parsippany. New Jersey. Ascend Laboratories LLC. is voluntarily recalling Dabigatran Etcxilate Capsules. USP 75 mg and 150 mg to the consumer/user level due to the presence of a nitrosamine. N-nitroso-dabigatran, above the established Acceptable Daily Intake (ADI) level. To date, Ascend Laboratories LLC.,

Cambridge, MA and Tarrytown, N.Y. February 28, 2023. The U.S. Food and Drug Administration (FDA) has approved Kevzara® (sarilumab) for the treatment of polymyalgia rheumatica (PMR), an inflammatory rheumatic disease, in adult patients who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. The approval is based on Phase 3 data

Treatment for Parkinson’s Disease AbbVie Provides Regulatory Update on ABBV-951 (Foscarbidopa/Foslevodopa) New Drug Application NORTH CHICAGO, Ill., March 22, 2023 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) for ABBV-951 (foscarbidopa/foslevodopa) for the treatment of

FDA Approves Rezzayo (rezafungin for injection) for the Treatment of Candidemia and Invasive Candidiasis SAN DIEGO & PARSIPPANY, N.J.–(BUSINESS WIRE)– March 22, 2023 — Cidara Therapeutics, Inc. (Nasdaq: CDTX) and Melinta Therapeutics, LLC today announced that the U.S. Food and Drug Administration (FDA) approved Rezzayo (rezafungin for injection) for the treatment of candidemia and invasive

tofersen Treatment for Amyotrophic Lateral Sclerosis Biogen Provides Update on FDA Advisory Committee Meeting on Tofersen for SOD1-ALS CAMBRIDGE, Mass., March 22, 2023 (GLOBE NEWSWIRE) — Biogen Inc. (Nasdaq: BIIB) announced today the outcome of the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee meeting on tofersen, an investigational

TARRYTOWN, N.Y., March 22, 2023 (GLOBE NEWSWIRE) — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has extended the approval of Evkeeza (evinacumab-dgnb) as an adjunct to other lipid-lowering therapies to treat children aged 5 to 11 with homozygous familial hypercholesterolemia (HoFH). Evkeeza is the first angiopoietin-like 3 (ANGPTL3)

FDA Approves Zynyz (retifanlimab-dlwr) for the Treatment of Metastatic or Recurrent Locally Advanced Merkel Cell Carcinoma (MCC) WILMINGTON, Del.–(BUSINESS WIRE)–Mar. 22, 2023– Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Zynyz™ (retifanlimab-dlwr), a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), for the treatment of adults with metastatic or

News New Drugs FDA Approves Expanded Indication for Telix’s Illuccix to Include Patient Selection for PSMA-Directed Radioligand Therapy Indianapolis, IN (United States) | 16 March 2023 — Telix Pharmaceuticals today announces that the United States Food and Drug Administration (FDA) has approved a supplementary New Drug Application (sNDA) for Illuccix® (kit for the preparation of

INDIANAPOLIS, March 3, 2023 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) approved an expanded indication for Verzenio (abemaciclib), in combination with endocrine therapy (ET), for the adjuvant treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early

Basel, March 16, 2023 — Novartis today announced the U.S. Food and Drug Administration (FDA) granted approval for Tafinlar® (dabrafenib) + Mekinist® (trametinib) for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. The FDA also approved liquid formulations of

FDA Approves Daybue (trofinetide) for the Treatment of Rett Syndrome SAN DIEGO–(BUSINESS WIRE)–Mar. 10, 2023– Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the U.S. Food and Drug Administration (FDA) has approved Daybue (trofinetide) for the treatment of Rett syndrome in adult and pediatric patients two years of age and older. Daybue is the first

TARRYTOWN, N.Y., Feb. 21, 2023 (GLOBE NEWSWIRE) — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for pozelimab as a treatment for adults and children as young as 1 year of age with CHAPLE disease (also known as CD55

elranatamab Pfizer’s Elranatamab Receives FDA and EMA Filing Acceptance NEW YORK–(BUSINESS WIRE) February 22, 2023 — Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the company’s Biologics License Application (BLA) for elranatamab, an investigational B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody (BsAb), for the treatment

“We are pleased that the FDA has accepted for filing our NDA resubmission for VP-102,” said Ted White, Verrica’s President and Chief Executive Officer. “With no FDA-approved treatments for molluscum, the filing acceptance of our NDA brings us one step closer towards providing a safe and effective therapeutic treatment option for the millions of patients

FDA Approves Zavzpret (zavegepant) Nasal Spray for the Acute Treatment of Migraine NEW YORK–(BUSINESS WIRE) March 10, 2023 — Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration (FDA) has approved Zavzpret (zavegepant), the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the acute treatment of migraine with

omecamtiv mecarbil Treatment for Heart Failure with Reduced Ejection Fraction Cytokinetics Receives Complete Response Letter From FDA for New Drug Application for Omecamtiv Mecarbil SOUTH SAN FRANCISCO, Calif., Feb. 28, 2023 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding

eplontersen Treatment for Hereditary Transthyretin-Mediated Amyloid Polyneuropathy (ATTRv-PN) Ionis Announces FDA Acceptance of New Drug Application for Eplontersen for the Treatment of Hereditary Transthyretin-Mediated Amyloid Polyneuropathy (ATTRv-PN) 35-week data included in the filing demonstrated a statistically significant and clinically meaningful change from baseline for co-primary and secondary endpoints compared to external placebo group Eplontersen previously

LEXINGTON, Mass.–(BUSINESS WIRE) March 2, 2023 –Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced that the U.S. Food and Drug Administration (FDA) accepted for Priority Review the New Drug Application (NDA) for ADX-2191 (methotrexate injection, USP), an investigational drug candidate, for the treatment of primary vitreoretinal lymphoma. The FDA assigned a Prescription Drug User Fee

Treatment for Narcolepsy Avadel Pharmaceuticals Requests Final FDA Approval for Lumryz (sodium oxybate) Extended-Release Oral Suspension DUBLIN, Ireland, March 02, 2023 (GLOBE NEWSWIRE) — Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that it has submitted an amendment to the U.S. Food and Drug Administration (“FDA”)

News FDA Alerts Pharmedica USA LLC Issues Voluntary Worldwide Recall of Purely Soothing 15% MSM Drops Due to Non-Sterility March 3, 2023 Audience: Consumer March 3, 2023 — Phoenix, Arizona, USA; Pharmedica USA LLC is voluntarily recalling two lots of Purely Soothing, 15% MSM Drops to the consumer level. This product is being recalled due

FDA Approves Altuviiio ([Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl]) Once-Weekly VIII Therapy for Hemophilia A Paris and Stockholm – February 23, 2023 – The U.S. Food and Drug Administration (FDA) has approved Altuviiio™ [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl], previously referred to as efanesoctocog alfa, a first-in-class, high-sustained factor VIII replacement therapy. Altuviiio is indicated