NDA News-CliniExpert

FDA Approves Pavblu (aflibercept-ayyh), a Biosimilar to Eylea

August 23, 2024 -- The U.S. Food and Drug Administration (FDA) has announced the approval of Pavblu (aflibercept-ayyh) 2 mg injection (single-dose prefilled syringe and single-dose vial) for intravitr

FDA Approves Crexont (carbidopa and levodopa) Extended-Release Capsules for the Treatment of Parkinson’s Disease

BRIDGEWATER, N.J.--(BUSINESS WIRE) August 7, 2024 -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approv

FDA Approves Rybrevant (amivantamab-vmjw) Plus Lazcluze (lazertinib) for Patients with EGFR-Mutated Advanced Lung cancer

RARITAN, N.J., Aug. 20, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) approved Rybrevant® (amivantamab-vmjw) plus Lazcluze™ (l

FDA Approves Niktimvo (axatilimab-csfr) for the Treatment of Chronic Graft-Versus-Host Disease (GVHD)

WILMINGTON, Del. & WALTHAM, Mass.--(BUSINESS WIRE)--Aug. 14, 2024 -- Incyte (Nasdaq:INCY) and Syndax Pharmaceuticals (Nasdaq:SNDX) today announced that the U.S. Food and Drug Administration (FDA)

FDA Grants Accelerated Approval for Livdelzi (seladelpar) for the Treatment of Primary Biliary Cholangitis

FOSTER CITY, Calif.--(BUSINESS WIRE) August 14, 2024 -- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Livde

FDA Approves Nemluvio (nemolizumab) for the Treatment of Adult Patients with Prurigo Nodularis

Zug, Switzerland – August 13, 2024 -- Galderma today announced that the U.S. Food and Drug Administration (FDA) has approved Nemluvio (nemolizumab) as a pre-filled pen for subcutaneous injection for t

FDA Approves neffy (epinephrine nasal spray) Needle-Free Treatment for Type I Allergic Reactions, Including Anaphylaxis

SAN DIEGO, Aug. 09, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients fr

FDA Approves Enzeevu (aflibercept-abzv), a Biosimilar to Eylea

Basel, August 12, 2024 -- Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration (FDA) has approved Enzeevu (afli

FDA Approves Yorvipath (palopegteriparatide) for the Treatment of Hypoparathyroidism in Adults

COPENHAGEN, Denmark, Aug. 12, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food & Drug Administration (FDA) has approved Yorvipath (palopegteriparatide

FDA Approves Zurnai (nalmefene hydrochloride) Auto-Injector for the Emergency Treatment of Known or Suspected Opioid Overdose

STAMFORD, Conn., August 7, 2024 -- Purdue Pharma L.P. (“Purdue”) announced today that the U.S. Food and Drug Administration (FDA) approved the Company’s new drug application for the Zurnai (nalmefene

FDA Approves Lymphir (denileukin diftitox-cxdl) Immunotherapy for the Treatment of Adults with Relapsed or Refractory Cutaneous T-Cell Lymphoma

CRANFORD, N.J., Aug. 8, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) ("Citius", "Citius Pharma"), announced today that the U.S. Food and Drug Administration (FD

FDA Approves Voranigo (vorasidenib) for the Treatment of Grade 2 IDH-Mutant Glioma

BOSTON, Mass. - August 6, 2024 -- Servier today announced that the U.S. Food and Drug Administration (FDA) has approved Voranigo, an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (I