NDA News-CliniExpert

FDA Approves Relyvrio (sodium phenylbutyrate/taurursodiol) for Patients with Amyotrophic Lateral Sclerosis (ALS)

Relyvrio (previously known as AMX0035 in the U.S.) is an oral, fixed-dose combination therapy for the treatment of adults with ALS Relyvrio significantly slowed loss of physical function in a randomiz

FDA Approves Iheezo (chloroprocaine hydrochloride ophthalmic gel) for Ocular Surface Anesthesia

Iheezo Represents the First Approved Use in the U.S. Ophthalmic Market of Chloroprocaine Hydrochloride and the First Branded Ocular Anesthetic Approved for the U.S. Ophthalmic Market in Nearly 14 Year

FDA Approves Vegzelma (bevacizumab-adcd), a Biosimilar to Avastin

Vegzelma is Celltrion’s third oncology biosimilar to receive approval from the U.S. FDA Vegzelma offers U.S. patients living with multiple types of cancer a new, safe, and effective treatment option T

FDA Approves Omlonti (omidenepag isopropyl ophthalmic solution) for Reduction of Elevated Intraocular Pressure in Primary Open-Angle Glaucoma or Ocular Hypertension

EMERYVILLE, Calif. & UBE, Japan--(BUSINESS WIRE) September 26, 2022 --Santen Inc., the U.S. subsidiary of Santen Pharmaceutical Co., Ltd. (Santen), and UBE Corporation (UBE) today announced that t

FDA Approves Pedmark (sodium thiosulfate injection) to Reduce Risk of Ototoxicity Associated with Cisplatin

Pedmark is the First and Only FDA-Approved Therapy Indicated to Reduce the Risk of Ototoxicity Associated with Cisplatin in Pediatric Patients with Localized, Non-Metastatic Solid Tumors RESEARCH TRIA

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