NDA News-CliniExpert

FDA Grants Accelerated Approval for Tecelra (afamitresgene autoleucel) Cell Therapy for the Treatment of Synovial Sarcoma

PHILADELPHIA & OXFORD, England--(BUSINESS WIRE) August 01, 2024 -- Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company working to redefine the treatment of solid tumor cancers with cell therapy

FDA Approves Erzofri (paliperidone palmitate) for the Treatment of Schizophrenia and Schizoaffective Disorder

PRINCETON, N.J., July 28, 2024 -- Luye Pharma Group (Luye Pharma), an international pharmaceutical company dedicated to the R&D, manufacturing and sales of innovative medications, today announced

FDA Approves Zunveyl (benzgalantamine) for the Treatment of Alzheimer's Disease

VANCOUVER, B.C., and Dallas, July 29, 2024 -- Alpha Cognition (CSE: ACOG) (OTCQB: ACOGF) (Alpha Cognition “ACI”, or the “Company”), a biopharmaceutical company developing novel therapeutics for debili

FDA Approves Leqselvi (deuruxolitinib), an Oral JAK Inhibitor for the Treatment of Severe Alopecia Areata

MUMBAI, India and PRINCETON, N.J., July 26, 2024 /PRNewswire/ -- Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, "Sun Pharma" and inc

FDA Approves Femlyv (norethindrone acetate and ethinyl estradiol) Orally Disintegrating Birth Control Pill

On July 22, 2024 -- the U.S. Food and Drug Administration (FDA) approved Femlyv (norethindrone acetate and ethinyl estradiol), the first orally disintegrating tablet approved for the prevention of pre

FDA Approves Epysqli (eculizumab-aagh), a Biosimilar to Soliris

INCHEON, South Korea, July 22, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA)

FDA Approves Nypozi (filgrastim-txid), a Biosimilar to Neupogen

July 01, 2024 -- Tanvex BioPharma, Inc. (TWSE: 6541) announced that The U.S. Food and Drug Administration (FDA) had completed their review of our submission of Nypozi (TX01) and approved the biologics

FDA Approves Kisunla (donanemab-azbt) for the Treatment of Early Symptomatic Alzheimer's Disease

INDIANAPOLIS, July 2, 2024 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) approved Kisunla™ (donanemab-azbt, 350 mg/20 mL once-monthly injection for IV infusion), Eli Lilly and Company

FDA Approves Pyzchiva (ustekinumab-ttwe), a Biosimilar to Stelara

Basel, July 1, 2024 -- Sandoz, the global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration (FDA) has approved biosimilar Pyzchiva®* (ustekinumab-ttw

FDA Approves Ahzantive (aflibercept-mrbb), a Biosimilar to Eylea

Planegg-Martinsried, Germany July 1, 2024 -- Formycon AG (FSE: FYB, “Formycon”) and its licensing partner Klinge Biopharma GmbH (“Klinge”) jointly announce that the U.S. Food and Drug Administration (

FDA Approves Tepylute (thiotepa) Ready-to-Dilute Injectable Formulation to Treat Breast Cancer and Ovarian Cancer

CAMBRIDGE, Mass.--(BUSINESS WIRE) June 28, 2024 -- Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has app

FDA Approves Ohtuvayre (ensifentrine) for the Maintenance Treatment of Chronic Obstructive Pulmonary Disease (COPD)

LONDON and RALEIGH, N.C., June 26, 2024 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), announces the US Food and Drug Administration (“FDA”) approved Ohtuvayr