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 Rezlidhia (olutasidenib) for Relapsed or Refractory Acute Myeloid Leukemia with a Susceptible IDH1 Mutation

December 01 2022

Rezlidhia is a potentially market-leading, oral, mutant isocitrate dehydrogenase-1 (mIDH1) inhibitor Phase 2 registrational data supporting the approval showed a 35% CR+CRh rate in mIDH1 R/R AML patients with a median duration of response of 25.9...

FDA Approves Rebyota (fecal microbiota, live-jslm) Microbiota-Based Live Biotherapeutic for the Prevention of Recurrence of Clostridioides Difficile Infection

November 30 2022

Ferring’s novel first-in-class Rebyota is indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older, following antibiotic treatment for recurrent CDI The safety and...

FDA Approves Hemgenix (etranacogene dezaparvovec-drlb) Gene Therapy for Hemophilia B

November 21 2022

This historic approval provides a new treatment option that reduces the rate of annual bleeds, reduces or eliminates the need for prophylactic therapy and generates elevated and sustained factor IX levels for years after a one-time infusion With...

FDA Approves Sezaby (phenobarbital sodium powder for injection) for the Treatment of Neonatal Seizures

November 18 2022

First and only product approved for treating seizures in neonatal patients Mumbai, India, November 18, 2022 – Sun Pharmaceutical Industries Limited and Sun Pharma Advanced Research Company Ltd. today announced that the U.S. Food and Drug...

FDA Approves Tzield (teplizumab-mzwv) to Delay the Onset of Stage 3 Type 1 Diabetes

November 16 2022

Tzield is the first disease-modifying therapy in T1D, a life-threatening autoimmune disease In a clinical trial, in Stage 2 T1D patients, Tzield delayed the median onset of Stage 3 T1D by 25 months, or approximately 2 years, compared to...

FDA Approves Medicines360’s Liletta (levonorgestrel-releasing intrauterine system) 52 mg to Prevent Pregnancy for up to Eight Years

November 14 2022

SAN FRANCISCO – Nov. 14, 2022 -- Medicines360, a global nonprofit organization with a mission to expand women’s access to quality medicines, announced today that the U.S. Food and Drug Administration (FDA) has approved...