NDA News-CliniExpert

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

FDA Approves PiaSky (crovalimab-akkz) for the Treatment of Paroxysmal Nocturnal Hemoglobinuria

June 24, 2024 -- The U.S. Food and Drug Administration (FDA) has approved PiaSky (crovalimab-akkz) for the treatment of adult and pediatric patients 13 years and older with paroxysmal nocturnal hemogl

FDA Approves Sofdra (sofpironium) Topical Gel for the Treatment of Primary Axillary Hyperhidrosis

Philadelphia and Phoenix US, 20 June 2024 -- Clinical dermatology company, Botanix Pharmaceuticals Ltd. (ASX:BOT, Botanix or the Company), is pleased to announce the US Food and Drug Administration (F

FDA Approves Capvaxive (pneumococcal 21-valent conjugate vaccine) for Prevention of Invasive Pneumococcal Disease and Pneumococcal Pneumonia in Adults

RAHWAY, N.J.--(BUSINESS WIRE) June 17, 2024 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved Ca

FDA Approves Vigafyde (vigabatrin) as the First and Only Ready-to-Use Vigabatrin Oral Solution

PARSIPPANY, N.J.--(BUSINESS WIRE) June 17, 2024 --Pyros Pharmaceuticals, Inc. (Pyros or the Company), a leader in the development of enhanced specialty pharmaceuticals for rare diseases, announced tod