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

September 29 2022

The U.S. Food and Drug Administration today approved Relyvrio (sodium phenylbutyrate/taurursodiol) to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig’s disease. “This approval provides another...

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

September 27 2022

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 The approval is based on totality of...

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

September 27 2022

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 Years Iheezo was Licensed by Harrow for the U.S....

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

September 26 2022

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 the U.S. Food and Drug Administration (FDA) has...

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

September 21 2022

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 TRIANGLE PARK, N.C., Sept. 21, 2022 (GLOBE...

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

September 18 2022

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)--Sep. 16, 2022-- bluebird bio, Inc. (Nasdaq:...