Category - New Drug Applications
Sarepta Therapeutics Completes Submission of New Drug Application Seeking Approval of Golodirsen (SRP-4053) in Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 53
Braeburn Announces Tentative FDA Approval of Brixadi (buprenorphine) Extended-Release Injection for the Treatment of Moderate to Severe Opioid Use Disorder
Pharmaxis Announces Resubmission of Bronchitol NDA
DBV Technologies Provides Update on Viaskin Peanut for Children Four to 11 Years of Age – BLA Withdrawn
Aimmune Therapeutics Submits BLA to FDA for AR101 for the Treatment of Peanut Allergy in Children and Adolescents Ages 4–17
Jazz Pharmaceuticals Receives New PDUFA Goal Date for Solriamfetol for Excessive Daytime Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea
Shield Therapeutics Announces the NDA for Feraccru has been Accepted for Filing and Review by FDA
Intra-Cellular Therapies Announces FDA Acceptance of New Drug Application for Lumateperone for the Treatment of Schizophrenia