NDA News-CliniExpert

FDA Approves Rolvedon (eflapegrastim-xnst) Injection to Decrease the Incidence of Chemotherapy-Induced Neutropenia

First novel Long-Acting GCSF (LA-GCSF) product approved in over 20 years Rolvedon™ developed using proprietary LAPSCOVERY™ technology with a differentiated molecular structure and proven safety and ef

FDA Approves Daxxify (daxibotulinumtoxinA-lanm) for Temporary Improvement of Moderate to Severe Glabellar Lines (Frown Lines)

NASHVILLE, Tenn.--(BUSINESS WIRE)--Sep. 8, 2022 -- Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced that th

FDA Approves Spevigo (spesolimab-sbzo) for Generalized Pustular Psoriasis (GPP) Flares in Adults

More than half of patients treated with Spevigo (spesolimab-sbzo) injection, for intravenous use showed no visible pustules one week after receiving treatment Spesolimab is a monoclonal antibody that

FDA Approves Xenpozyme (olipudase alfa-rpcp) for Non-CNS Manifestations of Acid Sphingomyelinase Deficiency (ASMD)

Paris, August 31, 2022 -- The U.S. Food and Drug Administration (FDA) has approved Xenpozyme (olipudase alfa-rpcp) for the treatment of non-central nervous system (non-CNS) manifestations of acid sphi

FDA Approves Auvelity (dextromethorphan and bupropion) for the Treatment of Major Depressive Disorder in Adults

Auvelity is the first and only rapid-acting oral treatment approved with labeling of statistically significant improvement in depressive symptoms compared to placebo starting at one week11-4 Auvelity

FDA Approves Zynteglo (betibeglogene autotemcel) Gene Therapy for People with Beta-Thalassemia Who Require Regular Red Blood Cell Transfusions

SOMERVILLE, Mass.--(BUSINESS WIRE)--Aug. 17, 2022 -- bluebird bio, Inc. (Nasdaq: BLUE) today announced the U.S. Food and Drug Administration (FDA) has approved Zynteglo® (betibeglogene autotemcel), al

FDA Approves Cimerli (ranibizumab-eqrn), an Interchangeable Biosimilar to Lucentis

REDWOOD CITY, Calif., Aug. 02, 2022 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Coherus or Coherus BioSciences, Nasdaq: CHRS) announced today that the U.S. Food and Drug Administration (FDA) has ap

FDA Approves Zoryve (roflumilast) Cream for the Treatment of Plaque Psoriasis

WESTLAKE VILLAGE, Calif., July 29, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovatio

FDA Approves Zonisade (zonisamide oral suspension) for the Treatment of Partial-Onset Seizures

The first and only FDA-approved zonisamide oral liquid formulation WOBURN, Mass., July 18, 2022 /PRNewswire/ -- Azurity Pharmaceuticals, Inc., a private pharmaceutical company focused on developing in

FDA Approves Bludigo (indigotindisulfonate sodium) for Cystoscopic Assessment of the Ureters Following Urological and Gynecological Surgical Procedures

Marseille, France and Collegeville, PA, USA – July 12, 2022 -- Provepharm, a French company specialized in the development of pharmaceutical applications, today announces that it has received FDA New

FDA Approves Amvuttra (vutrisiran) for the Treatment of the Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis in Adults

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jun. 13, 2022 -- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that the U.S. Food and Drug Administration (FDA

FDA Approves Priorix (Measles, Mumps and Rubella Vaccine, Live) for the Prevention of Measles, Mumps and Rubella in Individuals 12 Months of Age and Older

Priorix becomes an additional source of measles, mumps and rubella vaccine for US patients London UK 06 June 2022 -- GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (F