FDA Approves Ixchiq (Chikungunya Vaccine, Live) for the Prevention of Disease Caused by Chikungunya Virus

Saint-Herblain (France), November 10, 2023 -- Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the U.S. Food and Drug Administration (FDA) has approved

Latest News NDA News 4
Read All

FDA Approves Adzynma (ADAMTS13, recombinant-krhn) Enzyme Replacement Therapy for the Treatment of Congenital Thrombotic Thrombocytopenic Purpura (cTTP)

OSAKA, Japan & CAMBRIDGE, Mass., November 09, 2023--(BUSINESS WIRE) -- Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved Adzynma (ADAMTS13, r

Latest News NDA News 7
Read All

FDA Approves Zepbound (tirzepatide) for Chronic Weight Management

INDIANAPOLIS, Nov. 8, 2023 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) approved Eli Lilly and Company's (NYSE: LLY) Zepbound™ (tirzepatide) injection, the first and only obesity tr

Latest News NDA News 12
Read All

FDA Approves Fruzaqla (fruquintinib) for Previously Treated Metastatic Colorectal Cancer

OSAKA, Japan and CAMBRIDGE, Massachusetts, November 8, 2023 -- Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved Fruzaqla™ (fruquintinib), an ora

Latest News NDA News 20
Read All

FDA Approves Zituvimet (sitagliptin and metformin hydrochloride) to Treat Adult Patients With Type 2 Diabetes Mellitus

November 06, 2023, Ahmedabad, India -- Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as "Zydus") today announced that the U.S. Food and Drug Admini

Latest News NDA News 22
Read All

FDA Approves Voquezna (vonoprazan) for the Treatment of Erosive GERD and Relief of Heartburn Associated with Erosive GERD in Adults

FLORHAM PARK, N.J., Nov. 01, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastroint

Latest News NDA News 31
Read All

FDA Approves Wezlana (ustekinumab-auub), an Interchangeable Biosimilar to Stelara

October 31, 2023 -- Today, the U.S. Food and Drug Administration approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory disease

Latest News NDA News 38
Read All

FDA Approves Loqtorzi (toripalimab-tpzi) in All Lines of Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)

REDWOOD CITY, Calif. and SHANGHAI, China, Oct. 27, 2023 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus”, NASDAQ: CHRS), and Shanghai Junshi Biosciences Co., Ltd. (Junshi Biosciences, HKEX: 18

Latest News NDA News 35
Read All

FDA Approves Agamree (vamorolone) for the Treatment of Duchenne Muscular Dystrophy

CORAL GABLES, Fla., Oct. 26, 2023 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst" or "Company") (Nasdaq: CPRX) today reported that Santhera Pharmaceuticals ("Sa

Latest News NDA News 40
Read All

FDA Approves Omvoh (mirikizumab-mrkz), a First-in-Class Treatment for Adults with Moderately to Severely Active Ulcerative Colitis

INDIANAPOLIS, Oct. 26, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Omvoh™ (mirikizumab-mrkz) infusion (300 mg/1

Latest News NDA News 35
Read All

FDA Approves Penbraya (meningococcal groups A, B, C, W and Y vaccine) for the Prevention of the Five Most Common Serogroups Causing Meningococcal Disease in Adolescents

NEW YORK--(BUSINESS WIRE) October 20, 2023 -- Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved Penbraya™ (meningococcal groups A, B, C, W and Y vac

Latest News NDA News 63
Read All

FDA Approves Cabtreo (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel for the Treatment of Acne Vulgaris

LAVAL, Quebec, Oct. 20, 2023 -- Bausch Health Companies Inc. (NYSE/TSX: BHC) (“Bausch Health”) and its dermatology business, Ortho Dermatologics, today announced that the U.S. Food and Drug Administra

Latest News NDA News 61
Read All
News
- CLINIEXPERT -
Int'l Clinical Service Expert

We are the leader
Because of our professionism