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

Latest News NDA News 189
Read All

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

Latest News NDA News 146
Read All

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

Latest News NDA News 147
Read All

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

Latest News NDA News 212
Read All

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

Latest News NDA News 157
Read All

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

Latest News NDA News 123
Read All

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

Latest News NDA News 146
Read All

FDA Approves Zunveyl (benzgalantamine) for the Treatment of Alzheimer's Disease

VANCOUVER, B.C., and Dallas, July 29, 2024 -- Alpha Cognition (CSE: ACOG) (OTCQB: ACOGF) (Alpha Cognition “ACI”, or the “Company”), a biopharmaceutical company developing novel therapeutics for debili

Latest News NDA News 178
Read All

FDA Approves Leqselvi (deuruxolitinib), an Oral JAK Inhibitor for the Treatment of Severe Alopecia Areata

MUMBAI, India and PRINCETON, N.J., July 26, 2024 /PRNewswire/ -- Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, "Sun Pharma" and inc

Latest News NDA News 271
Read All

FDA Approves Femlyv (norethindrone acetate and ethinyl estradiol) Orally Disintegrating Birth Control Pill

On July 22, 2024 -- the U.S. Food and Drug Administration (FDA) approved Femlyv (norethindrone acetate and ethinyl estradiol), the first orally disintegrating tablet approved for the prevention of pre

Latest News NDA News 131
Read All

FDA Approves Epysqli (eculizumab-aagh), a Biosimilar to Soliris

INCHEON, South Korea, July 22, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA)

Latest News NDA News 183
Read All

FDA Approves Nypozi (filgrastim-txid), a Biosimilar to Neupogen

July 01, 2024 -- Tanvex BioPharma, Inc. (TWSE: 6541) announced that The U.S. Food and Drug Administration (FDA) had completed their review of our submission of Nypozi (TX01) and approved the biologics

Latest News NDA News 141
Read All
News
- CLINIEXPERT -
Int'l Clinical Service Expert

We are the leader
Because of our professionism