NDA News-CliniExpert

FDA Approves Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) for the Prevention of Invasive Pneumococcal Disease in Adults

KENILWORTH, N.J.--(BUSINESS WIRE) -- (NYSE: MRK), known as MSD outside the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) approved Vaxneuvance (Pneumococcal 15-v

FDA Approves Kerendia (finerenone) for the Treatment of Patients with Chronic Kidney Disease Associated with Type 2 Diabetes

WHIPPANY, N.J.-- July 9, 2021 (BUSINESS WIRE) -- Bayer announced today the United States (U.S.) Food and Drug Administration (FDA) has approved Kerendia (finerenone), a first-in-class nonsteroidal min

FDA Approves Rylaze for the Treatment of Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

DUBLIN, June 30, 2021 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the U.S. Food and Drug Administration (FDA) approval of Rylaze (asparaginase erwinia chrysanthemi (recombi

FDA Approves Verkazia (cyclosporine ophthalmic emulsion) for the Treatment of Vernal Keratoconjunctivitis

EMERYVILLE, Calif.--(BUSINESS WIRE) June 24, 2021 -- Santen Inc., the U.S. subsidiary of Santen Pharmaceutical Co., Ltd. (hereinafter, Santen), a global company focused exclusively on eye care, today

FDA Approves Astepro Allergy (azelastine) Nasal Spray for Over-the-Counter Use

WHIPPANY, N.J.--(BUSINESS WIRE) June 17, 2021 -- Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved Astepro Allergy (Azelastine HCI .15%) as an over-the-counter (OTC)

FDA Approves Rezipres (ephedrine hydrochloride injection) for Hypotension During Anesthesia

DEER PARK, Ill., June 15, 2021 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON) today announced that the U.S. Food and Drug Administration (FDA) has approved Rezipres (ephedrine hydrochlor

FDA Approves Soaanz (torsemide) for Edema Treatment in Patients with Heart Failure and Renal Disease

VIENNA, VA. (PRWEB) JUNE 21, 2021 -- Sarfez Pharmaceuticals announced today approval by the U.S. Food and Drug Administration (FDA) of the Virginia-based company’s New Drug Application for Soaanz, a o

FDA Approves Prevnar 20 (pneumococcal 20-valent conjugate vaccine) for Adults Ages 18 Years or Older

First approval of a conjugate vaccine that helps protect against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia,1,2,3,4,5,6,7 including seven responsible for

FDA Grants Accelerated Approval for Aduhelm (aducanumab-avwa) for the Treatment of Alzheimer’s Disease

CAMBRIDGE, Mass. and TOKYO, June 07, 2021 (GLOBE NEWSWIRE) -- Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan) today announced that the U.S. Food and Drug Administration (FDA) has granted acc

FDA Approves Wegovy (semaglutide) to Treat Adults with Obesity

PLAINSBORO, N.J., June 4, 2021 /PRNewswire/ -- Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved the new drug application (NDA) for Wegovy™ (semaglutide) injecti

FDA Approves Ryplazim (plasminogen, human-tvmh) for the Treatment of Plasminogen Deficiency Type 1

LAVAL, QC and CAMBRIDGE, England, June 4, 2021 /CNW Telbec/ - Liminal BioSciences Inc. (Nasdaq: LMNL) ("Liminal BioSciences" or the "Company") announced today that the U.S. Food &a

FDA Approves Tembexa (brincidofovir) for the Treatment of Smallpox

DURHAM, N.C., June 04, 2021 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases, tod