new drug approvals

New drug approvals news from Drugs.com. Comprehensive and up-to-date drug news for both consumers and healthcare professionals.
  1. Lytgobi (pronounced “light-GOH-bee”) delivered an objective response rate of 42% and median duration of response of 9.7 months in the primary analysis of the pivotal clinical trial. Lytgobi covalently binds to FGFR2 and inhibits the...
  2. Firdapse is Now a Treatment Option for All LEMS Patients 6 Years of Age and Older in the U.S. CORAL GABLES, Fla., Sept. 29, 2022 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst") (Nasdaq: CPRX), a commercial-stage...
  3. 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 randomized, placebo-controlled clinical trial in...
  4. Dupixent significantly reduced itch and skin lesions compared to placebo in direct-to-Phase 3 program consisting of two pivotal trials About 75,000 adults in the U.S. living with prurigo nodularis are most in need of new treatment...
  5. 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...