NDA News-CliniExpert

FDA Approves Fylnetra (pegfilgrastim-pbbk), a Biosimilar to Neulasta

BRIDGEWATER, N.J.--(BUSINESS WIRE)-- May 27, 2022 -- Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (“FDA”) has approv

FDA Approves Vtama (tapinarof) Cream for the Treatment of Plaque Psoriasis in Adults

LONG BEACH, Calif., and BASEL, Switzerland, May 24, 2022 -- Dermavant Sciences, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, t

FDA Approves Mounjaro (tirzepatide) Injection for the Treatment of Adults with Type 2 Diabetes

INDIANAPOLIS, May 13, 2022 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) approved Mounjaro (tirzepatide) injection, Eli Lilly and Company's (NYSE: LLY) new once-weekly GIP (glucose-d

FDA Approves Radicava ORS (edaravone) for the Treatment of Amyotrophic Lateral Sclerosis (ALS)

JERSEY CITY, N.J., May 13, 2022 /PRNewswire/ -- Mitsubishi Tanabe Pharma Corporation (MTPA) today announced the U.S. Food and Drug Administration (FDA) has approved Radicava ORS (edaravone), the oral

FDA Approves Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin) for the Treatment of H. pylori Infection in Adults

Voquezna Triple and Dual Paks each contain vonoprazan, a novel, first-in-class potassium-competitive acid blocker (PCAB), and have demonstrated superior eradication rates vs. lansoprazole-based triple

FDA Approves Camzyos (mavacamten) for the Treatment of Symptomatic NYHA Class II-III Obstructive Hypertrophic Cardiomyopathy

PRINCETON, N.J.--(BUSINESS WIRE) -- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Camzyos (mavacamten, 2.5 mg, 5 mg, 10 mg, 15 mg capsules)

FDA Approves Cuvrior (trientine tetrahydrochloride) for the Treatment of Wilson’s disease

Paris, France 2 May 2022 -- Orphalan SA (“Orphalan” or “the Company”), an international orphan drug development and commercialisation company, today announces approval of Cuvrior™, a new salt of trien

FDA Approves Vivjoa (oteseconazole) for the Treatment of Recurrent Vulvovaginal Candidiasis (Chronic Yeast Infection)

DURHAM, N.C.--(BUSINESS WIRE) -- The U.S. Food and Drug Administration (FDA) approved Vivjoa (oteseconazole capsules), an azole antifungal indicated to reduce the incidence of recurrent vulvovaginal c

FDA Approves Epsolay (benzoyl peroxide) Cream for the Treatment of Rosacea

NESS ZIONA, Israel and ZUG, Switzerland, April 25, 2022 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology company focused on identifying, developing and commercializing bran

FDA Approves Alymsys (bevacizumab-maly), a Biosimilar to Avastin

BRIDGEWATER, N.J.--(BUSINESS WIRE) April 13, 2022 -- Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved

FDA Approves Vijoice (alpelisib) for the Treatment of PIK3CA-Related Overgrowth Spectrum (PROS)

Vijoice is first approved treatment to specifically address the root cause of PROS conditions in select patients 2 years of age and older1 PROS is a spectrum of rare conditions and is characterized by

FDA Approves Igalmi (dexmedetomidine) Sublingual Film for Acute Treatment of Agitation Associated with Schizophrenia or Bipolar I or II Disorder in Adults

NEW HAVEN, Conn., April 06, 2022 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence (AI) approaches to identify and develop tr