NDA News-CliniExpert

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

FDA Approves Blenrep (belantamab mafodotin-blmf) for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma

London UK 05 August 2020 -- GlaxoSmithKline announced the US Food and Drug Administration (FDA) has approved Blenrep (belantamab mafodotin-blmf) as a monotherapy treatment for adult patients with rela

FDA Approves Monjuvi (tafasitamab-cxix) in Combination with Lenalidomide for the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) Print this page

PLANEGG/MUNICH, Germany - August 1, 2020 and WILMINGTON, Del. - July 31, 2020 -- MorphoSys AG NASDAQ:MOR) and Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has

FDA Approves Tecartus (brexucabtagene autoleucel) as the First and Only CAR T Treatment for Relapsed or Refractory Mantle Cell Lymphoma

SANTA MONICA, Calif.--(BUSINESS WIRE)--Jul. 24, 2020 -- Kite, a Gilead Company (Nasdaq: GILD), today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Teca

FDA Approves Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) for the Maintenance Treatment of COPD Print this page

24 July 2020 -- AstraZeneca’s Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) has been approved in the US for the maintenance treatment of patients with chronic obstructive pulmonar

FDA Approves Xywav (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for Cataplexy or Excessive Daytime Sleepiness Associated with Narcolepsy

DUBLIN, July 22, 2020 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) approved Xywav™ (calcium, magnesium, potassium, and sodiu