NDA News-CliniExpert

FDA Approves Zilbrysq (zilucoplan) for the Treatment of Adults with Generalized Myasthenia Gravis

ATLANTA, Oct. 17, 2023 /PRNewswire/ -- UCB (Euronext Brussels: UCB), a global biopharmaceutical company, today announced that Zilbrysq® (zilucoplan) has been approved by the U.S. Food and Drug Adminis

FDA Approves Xphozah (tenapanor) to Reduce Serum Phosphorus in Adults with Chronic Kidney Disease

WALTHAM, Mass., Oct. 17, 2023 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class med

FDA Approves Qlosi (pilocarpine hydrochloride ophthalmic solution) 0.4% for the Treatment of Presbyopia

PONTE VEDRA, Fla., Oct. 18, 2023 /PRNewswire/ -- Orasis Pharmaceuticals, an emerging ophthalmic pharmaceutical company focused on reshaping vision possibilities, today announced that the U.S. Food and

FDA Approves Bimzelx (bimekizumab-bkzx) for the Treatment of Adults with Moderate to Severe Plaque Psoriasis

Brussels (Belgium), 18 OCTOBER 2023 – UCB, a global biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved Bimzelx® (bimekizumab-bkzx) for the treatme

FDA Approves Velsipity (etrasimod) for Adults with Moderately to Severely Active Ulcerative Colitis (UC)

NEW YORK--(BUSINESS WIRE) October 13, 2023 -- Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved Velsipity™ (etrasimod), an oral, once-daily, selecti

FDA Approves Tofidence (tocilizumab-bavi), a Biosimilar to Actemra

CAMBRIDGE, Mass., Sept. 29, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) has approved Tofidence (tocilizumab-bavi) intravenous formula

FDA Approves Rivfloza (nedosiran) for the Treatment of Primary Hyperoxaluria Type 1 (PH1)

PLAINSBORO, N.J., Oct. 2, 2023 /PRNewswire/ -- Novo Nordisk announced today that the U.S. Food and Drug Administration (FDA) has approved Rivfloza (nedosiran) injection 80 mg, 128 mg, or 160 mg, a onc

FDA Approves Technegas (Technetium Tc 99-m Labeled Carbon) Radioactive Diagnostic Agent

October 2, 2023 -- Cyclopharm Limited (ASX: CYC) announces the company has received United States Food and Drug Administration (USFDA) approval to commence commercial sales of Technegas in the US mark

FDA Approves Pombiliti (cipaglucosidase alfa-atga) + Opfolda (miglustat) for the Treatment of Late-Onset Pompe Disease

PHILADELPHIA, Sept. 28, 2023 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that the U.S. Food and Drug Administration (FDA) has approved Pombiliti™ (cipaglucosidase alfa-atga)

FDA Approves Ryzumvi (phentolamine) Ophthalmic Solution for the Treatment of Pharmacologically-Induced Mydriasis

FARMINGTON HILLS, Mich., and PITTSBURGH, Sept. 27, 2023 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commer

FDA Approves Likmez (metronidazole) Oral Suspension for the Treatment of Parasitic and Anaerobic Bacterial Infections

HALIFAX, Nova Scotia--(BUSINESS WIRE) September 25, 2023 -- Appili Therapeutics Inc. (TSX:APLI; OTCQB: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for i

FDA Approves Ojjaara (momelotinib) for Myelofibrosis Patients with Anemia

Approval is for use in myelofibrosis patients with anemia regardless of prior myelofibrosis therapy Nearly all myelofibrosis patients are estimated to develop anemia over the course of the disease, an