New Product Newswire
FDA Roundup: ATX101 Gains Breakthrough Therapy Designation, Stelara Biosimilar Approval
Catch up on important FDA news from the week of December 2.
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.
FDA Accepts BLA Resubmission for Epidermolysis Bullosa Gene Therapy
The agency assigned prademagene zamikeracel a PDUFA target action date of April 29, 2025.
FDA Roundup: Rosacea Treatment, Proposal to Remove Oral Phenylephrine from OTC Products
Check out these important FDA updates from the week of November 4.
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.
