New MS Biosimilar, RSV Maternal Immunization, Rybrevant in Advanced NSCLC, Xtandi in Early PCa

New FDA Approvals

Summary:

In this week's New FDA Approval's podcast episode, Dr. Emma Hitt Nichols discusses the latest FDA approvals from August 21, 2023 – August 25, 2023. Please check back every Monday morning so that you can stay up to date.

See more details summaries and links to prescribing information at nascentmc.com/podcast

Here are the highlights:

FDA Approves Tyruko as First Biosimilar to TysabriThe FDA approved Tyruko as the first biosimilar to Tysabri for treating relapsing forms of MS in adults. It has similar risks and side effects as Tysabri and is also approved for treating certain Crohn’s Disease patients. The product is available from Sandoz Inc. Source Abrysvo RSV Maternal Immunization ApprovedThe FDA approved Abrysvo, a vaccine for preventing respiratory disease caused by RSV in infants through maternal immunization. The approval is based on Phase 3 MATISSE trial results. Abrysvo was also approved for older adults earlier this year. Source sBLA Filed for Rybrevant in Advanced NSCLCAn sBLA was filed for expanded approval of Rybrevant, combined with certain drugs, for treating advanced non–small cell lung cancer with EGFR exon 20 insertion mutations. The approval was granted to Janssen Pharmaceuticals. Source Priority Review of Xtandi in Early PCaXtandi received Priority Review by the FDA for an expanded use in early-stage prostate cancer. The sNDA is based on a Phase 3 EMBARK trial, where Xtandi showed significant benefits. The product is manufactured by Pfizer, Inc.

Intro and outro music

Garden Of Love by Pk jazz Collective