NDA News-CliniExpert

FDA Approves Aponvie (aprepitant) for the Prevention of Postoperative Nausea and Vomiting (PONV)

Aponvie is the first and only intravenous (IV) formulation of a substance P/neurokinin-1 (NK1) receptor antagonist indicated for PONV Delivered via a single 30-second IV injection, Aponvie has demonst

FDA Approves Skysona (elivaldogene autotemcel) Gene Therapy for Early, Active Cerebral Adrenoleukodystrophy (CALD)

Skysona is the first FDA approved therapy shown to slow the progression of neurologic dysfunction in boys with this devastating and fatal neurodegenerative disease SOMERVILLE, Mass.--(BUSINESS WIRE)--

FDA Approves Terlivaz (terlipressin) for the Treatment of Hepatorenal Syndrome (HRS)

DUBLIN, Sept. 14, 2022 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKPF), a global specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved Terlivaz

FDA Approves Sotyktu (deucravacitinib) for the Treatment of Adults with Moderate-to-Severe Plaque Psoriasis

Bristol Myers Squibb’s Sotyktu, a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, is the only approved TYK2 inhibitor worldwide and the first innovation in oral treatme

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