New Drug Approvals

New drug approvals news from Drugs.com. Comprehensive and up-to-date drug news for both consumers and healthcare professionals.

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

August 01 2020

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 approved Monjuvi (tafasitamab-cxix) in combination...

FDA Approves Xeglyze (abametapir) Lotion for the Treatment of Head Lice

July 27 2020

HYDERABAD, India & PRINCETON, N.J.--(BUSINESS WIRE) July 27, 2020 --Dr. Reddy’s Laboratories Ltd. today announced approval of Xeglyze (abametapir) lotion, 0.74%, a 505(b)(1) NDA by the U.S. Food and Drug Administration. The approval...

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

July 24 2020

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 Tecartus™ (brexucabtagene...

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

July 24 2020

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 pulmonary disease (COPD). The approval by the US...

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

July 21 2020

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 sodium oxybates)...

FDA Approves Wynzora Cream (calcipotriene and betamethasone dipropionate) for Adults with Plaque Psoriasis

July 21 2020

COPENHAGEN, Denmark, July 22, 2020 / B3C newswire / -- MC2 Therapeutics, a commercial stage pharmaceutical company developing a new standard of topical therapies for chronic inflammatory conditions, announced today that the U.S. Food and Drug...