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FDA Approves Veopoz (pozelimab-bbfg) as the First Treatment for Children and Adults with CHAPLE Disease

TARRYTOWN, N.Y., Aug. 18, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has approved Veopoz™ (pozelimab-bbfg) for

FDA Approves Sohonos (palovarotene) for the Treatment of Fibrodysplasia Ossificans Progressiva

PARIS, FRANCE, 16 August 2023 -- Ipsen (Euronext: IPN; ADR: IPSEY) announced today approval by the U.S. Food and Drug Administration (FDA) of Sohonos™ (palovarotene) capsules as a retinoid indicated f

FDA Approves Hepzato Kit (melphalan) Hepatic Delivery System for the Treatment of Unresectable Hepatic-Dominant Metastatic Uveal Melanoma

NEW YORK, Aug. 14, 2023 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced that

FDA Grants Accelerated Approval for Elrexfio (elranatamab-bcmm) for Relapsed or Refractory Multiple Myeloma

The approval of Elrexfio (elranatamab-bcmm) is based on clinically meaningful response rates and duration of response from Phase 2 MagnetisMM-3 study Elrexfio is the first off-the-shelf (ready-to-use)

FDA Approves Akeega (niraparib and abiraterone acetate) for the Treatment of Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer

HORSHAM, Pa., August 11, 2023 -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food & Drug Administration (FDA) has approved Akeega™ (niraparib and ab

FDA Approves Talvey (talquetamab-tgvs), a First-in-Class Bispecific Therapy for the Treatment of Patients with Heavily Pretreated Multiple Myeloma

HORSHAM, Pa., Aug. 10, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Talvey™

FDA Approves Zurzuvae (zuranolone) First Oral Treatment for Postpartum Depression

Postpartum depression (PPD) approval based on results from two Phase 3 clinical trials; in the SKYLARK Study treatment with Zurzuvae rapidly improved symptoms of PPD at Day 15 and as early as Day 3 wi

FDA Approves Izervay (avacincaptad pegol) Intravitreal Solution for the Treatment for Geographic Atrophy

TOKYO, Aug. 5, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas"), today announced the U.S. Food and Drug Administration (FDA) approved Izerv

FDA Approves RiVive (naloxone hydrochloride) Over-the-Counter Nasal Spray for the Emergency Treatment of Opioid Overdose

Pittsburgh, Pennsylvania--(Newsfile Corp. - July 28, 2023) -- Harm Reduction Therapeutics (HRT), Inc., a nonprofit pharmaceutical company, announced today that FDA has approved OTC RiVive™ (naloxone H

FDA Approves Xdemvy (lotilaner) Ophthalmic Solution for the Treatment of Demodex Blepharitis

IRVINE, Calif., July 25, 2023 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize tre

FDA Approves Ycanth (cantharidin) Topical Solution for the Treatment of Molluscum Contagiosum

WEST CHESTER, PA –Jul 21, 2023 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medica

FDA Approves Balfaxar (prothrombin complex concentrate, human-lans) for Warfarin Reversal in Urgent Surgery & Invasive Procedures

PARAMUS, N.J., July 26, 2023 /PRNewswire/ -- Octapharma USA today announced that Balfaxar® (prothrombin complex concentrate, human-lans; marketed in Europe and Canada as octaplex®) has received U.S. F