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
FDA Approves Vanflyta (quizartinib) for Patients with Newly Diagnosed FLT3-ITD Positive Acute Myeloid Leukemia
TOKYO & BASKING RIDGE, N.J. July 20, 2023 --(BUSINESS WIRE)--Daiichi Sankyo (TSE: 4568) today announced that Vanflyta (quizartinib) has been approved by the U.S. Food and Drug Administration (FDA)
FDA Approves Cyfendus (Anthrax Vaccine Adsorbed, Adjuvanted) Two-Dose Anthrax Vaccine for Post-Exposure Prophylaxis Use
GAITHERSBURG, Md., July 20, 2023 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) announced today that the U.S. Food and Drug Administration (FDA) has approved Cyfendus (Anthrax Vaccine Adsor
FDA Approves Beyfortus (nirsevimab) for the Prevention of RSV Lower Respiratory Tract Disease in Infants
July 17, 2023 -- AstraZeneca and Sanofi’s Beyfortus (nirsevimab) has been approved in the US for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns
FDA Approves Opill (norgestrel) OTC Daily Oral Contraceptive
DUBLIN, July 13, 2023 /PRNewswire/ -- Perrigo Company plc (NYSE: PRGO), a leading provider of Consumer Self-Care Products, announced today that the U.S. Food and Drug Administration (FDA) approved Opi
FDA Approves Roctavian (valoctocogene roxaparvovec-rvox) Gene Therapy for Adults with Severe Hemophilia A
SAN RAFAEL, Calif., June 29, 2023 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN), a global biotechnology company dedicated to transforming lives through genetic discovery, today announced
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