Oncologic Drugs Advisory Committee (ODAC)

FDA’s ODAC Votes Against Merck’s Keytruda For TNBC

Advisory Committees, Blockbusters, Checkpoint Inhibitors, Chemotherapy, Clinical Trials, Early-Stage Triple-Negative Breast Cancer (TNBC), FDA, FDA, High-Risk, Keytruda, Not Recommended For Approval, Oncologic Drugs Advisory Committee (ODAC), R&D, Therapeutics

The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) voted against recommending Merck’s checkpoint inhibitor Keytruda (pembrolizumab) as neoadjuvant treatment for high-risk, early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy after surgery.

FDA Rejects Mesoblast’s Ryoncil for Pediatric GVHD

FDA, Oncologic Drugs Advisory Committee (ODAC)

The U.S.Food and Drug Administration issued a Complete Response Letter for Mesoblast’s Biologics License Application for Ryoncil (remestemcel-L).

FDA Action Alert: Aquestive, Eton and Mesoblast

Adrenal Glands, Adrenal Insufficiency, Business, Clinical Trials, Congenital Adrenal Hyperplasia (CAH), Epilepsy, FDA/Regulatory, Glands, New Drug Application (NDA), Oncologic Drugs Advisory Committee (ODAC), PDUFA, Pediatric, Quarterly results, R&D, Seizure Clusters

The U.S. Food and Drug Administration is wrapping up the month of September with a few PDUFA dates, including an approval review of Aquestive’s Libervant for the management of seizure clusters in epilepsy.