NDA News-CliniExpert

FDA Approves Zonisade (zonisamide oral suspension) for the Treatment of Partial-Onset Seizures

The first and only FDA-approved zonisamide oral liquid formulation WOBURN, Mass., July 18, 2022 /PRNewswire/ -- Azurity Pharmaceuticals, Inc., a private pharmaceutical company focused on developing in

FDA Approves Bludigo (indigotindisulfonate sodium) for Cystoscopic Assessment of the Ureters Following Urological and Gynecological Surgical Procedures

Marseille, France and Collegeville, PA, USA – July 12, 2022 -- Provepharm, a French company specialized in the development of pharmaceutical applications, today announces that it has received FDA New

FDA Approves Amvuttra (vutrisiran) for the Treatment of the Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis in Adults

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jun. 13, 2022 -- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that the U.S. Food and Drug Administration (FDA

FDA Approves Priorix (Measles, Mumps and Rubella Vaccine, Live) for the Prevention of Measles, Mumps and Rubella in Individuals 12 Months of Age and Older

Priorix becomes an additional source of measles, mumps and rubella vaccine for US patients London UK 06 June 2022 -- GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (F

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