What you need to know about the FDA’s most recent novel drug approvals.
FDA Accepts BLA Resubmission for Epidermolysis Bullosa Gene Therapy
The agency assigned prademagene zamikeracel a PDUFA target action date of April 29, 2025.
Episode 8: Stay in Sync with Innovations in Medication Decision Support
Episode 8 of Over the Counter discusses the new and exciting modernizations in the medication decision support space.
Lumateperone Demonstrates Efficacy in Reducing Symptomatic Relapse Risk in Schizophrenia
The drug is also approved to treat schizophrenia and bipolar depression.
FDA Approves Journey Medical’s Emrosi for Rosacea
“Emrosi has potential to become the best-in-class oral medication to treat the condition,” said the CEO of Journey Medical.
FDA Expands OA REMS, Mandates Mail-Back Envelopes for Opioid Analgesics
The FDA has mandated that companies participating in the Opioid Analgesic Risk Evaluation and Mitigation Strategy program provide pre-paid mail-back envelopes for unused or expired opioid medications.
FDA Roundup: Agency Highlights from October 2024
Check out these important FDA updates from the month of October 2024.
