NDA News-CliniExpert

FDA Approves Aqneursa (levacetylleucine) for the Treatment of Niemann-Pick Disease Type C

AUSTIN, TX, September 25, 2024 -- IntraBio Inc., a leader in the discovery and development of innovative drugs for rare neurodegenerative diseases, today announced that the U.S. Food and Drug Administ

FDA Approves Miplyffa (arimoclomol) for the Treatment of Niemann-Pick Disease Type C

CELEBRATION, Fla., Sept. 20, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a commercial-stage rare disease therapeutics company, today announced that the

FDA Approves Ebglyss (lebrikizumab-lbkz) for the Treatment of Atopic Dermatitis

INDIANAPOLIS, Sept. 13, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today the U.S. Food and Drug Administration (FDA) approved Ebglyss (lebrikizumab-lbkz), a targeted IL-13 inhibi

FDA Approves Ocrevus Zunovo (ocrelizumab & hyaluronidase-ocsq) Twice-A-Year Subcutaneous Injection for People With Relapsing and Progressive Multiple Sclerosis

South San Francisco, CA -- September 13, 2024 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the United States Food and Drug Administration (U.S. FDA) has

FDA Approves Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) Subcutaneous Anti-PD-(L)1 Cancer Immunotherapy

South San Francisco, CA -- September 12, 2024 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Tece

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