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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

FDA Grants Accelerated Approval for Tecelra (afamitresgene autoleucel) Cell Therapy for the Treatment of Synovial Sarcoma

PHILADELPHIA & OXFORD, England--(BUSINESS WIRE) August 01, 2024 -- Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company working to redefine the treatment of solid tumor cancers with cell therapy

FDA Approves Erzofri (paliperidone palmitate) for the Treatment of Schizophrenia and Schizoaffective Disorder

PRINCETON, N.J., July 28, 2024 -- Luye Pharma Group (Luye Pharma), an international pharmaceutical company dedicated to the R&D, manufacturing and sales of innovative medications, today announced