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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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