NDA News-CliniExpert

FDA Approves Gavreto (pralsetinib) for the Treatment of Adults With Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

South San Francisco, CA -- September 4, 2020 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Gavre

Regeneron Announces American College of Cardiology Presentation of Positive Phase 3 Evinacumab Results in Patients with Severe Inherited Form of High Cholesterol

TARRYTOWN, N.Y., March 30, 2020 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that detailed Phase 3 results of evinacumab were presented today as a late-breaking presentatio

FDA Approves Onureg (azacitidine tablets) as Continued Treatment for Adults in First Remission with Acute Myeloid Leukemia

PRINCETON, N.J.--(BUSINESS WIRE) September 1, 2020 -- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Onureg (azacitidine 300 mg tablets,

FDA Approves Xaracoll (bupivacaine hydrochloride) Implant for Acute Postsurgical Pain Relief Following Open Inguinal Hernia Repair

ATHLONE, Ireland, Aug. 31, 2020 /PRNewswire/ -- Innocoll Holdings Limited, a specialty pharmaceutical company and portfolio business of Gurnet Point Capital, announced today that the US Food and Drug

FDA Approves Sogroya (somapacitan-beco) a Once-Weekly Treatment for Adult Growth Hormone Deficiency

Plainsboro, NJ, Aug 28, 2020 -- Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application for Sogroya (somapacitan-beco) injection 10

FDA Approves Winlevi (clascoterone) Cream for the Treatment of Acne

Lainate, Italy – August 27, 2020 – Cassiopea SpA (SIX: SKIN), today announced that the United States Food and Drug Administration (FDA) approved Winlevi (clascoterone cream 1%) for the treatment of ac

FDA Approves Kesimpta (ofatumumab) Targeted B-cell Therapy for Patients with Relapsing Multiple Sclerosis

Basel, August 20, 2020 -- Novartis today announced that the US Food and Drug Administration (FDA) has approved Kesimpta® (ofatumumab, formerly OMB157) as an injection for subcutaneous use for the trea

FDA Approves Enspryng (satralizumab-mwge) for Neuromyelitis Optica Spectrum Disorder

South San Francisco, CA -- August 14, 2020 -- Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration (FDA) has approved Enspryng (satralizumab-mwge) as the

FDA Approves Viltepso (viltolarsen) for the Treatment of Duchenne Muscular Dystrophy in Patients Amenable to Exon 53 Skipping Therapy Print this page

PARAMUS, N.J., Aug. 12, 2020 /PRNewswire/ -- NS Pharma, Inc. announced today that the U.S. Food & Drug Administration (FDA) has approved Viltepso (viltolarsen) injection for patients with Duchenne

FDA Approves Evrysdi (risdiplam) for Treatment of Spinal Muscular Atrophy (SMA) in Adults and Children 2 Months and Older

South San Francisco, CA -- August 7, 2020 -- Genentech, a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) has approved Evrysdi (risdiplam) for treatment of

FDA Approves Olinvyk (oliceridine) Injection for the Management of Severe Acute Pain

CHESTERBROOK, Pa., Aug. 10, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with cen

FDA Approves Lampit (nifurtimox) for the Treatment of Chagas Disease in Children

WHIPPANY, N.J.--(BUSINESS WIRE) August 7, 2020 -- Bayer announced today that the United States Food and Drug Administration (FDA) has approved Lampit (nifurtimox) for use in pediatric patients (from b