FDA Approves Aphexda (motixafortide) to Mobilize Hematopoietic Stem Cells for Autologous Transplantation in Patients with Multiple Myeloma
Aphexda is the first innovation in stem cell mobilization for multiple myeloma to be approved in the U.S. in a decade One dosage of Aphexda plus filgrastim enabled a majority of patients to achieve th
FDA Approves Tyruko (natalizumab-sztn), a Biosimilar to Tysabri
August 24, 2023 -- The U.S. Food and Drug Administration today approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection for the treatment of adults with relapsing fo
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
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