The FDA extended the review period for Capricor Therapeutics' experimental cell therapy deramiocel for Duchenne muscular dystrophy by three months after the company submitted new data with a refined indication.
The U.S. Food and Drug Administration will convene its Molecular and Clinical Genetics Panel on September 23, 2026, to review Grail's premarket approval application for Galleri, a multi-cancer early detection test. The advisory committee meeting represents a critical regulatory milestone for the company, which anticipates a potential approval decision in early 2027.
The U.S. Food and Drug Administration will convene its Molecular and Clinical Genetics Panel on September 23, 2026, to review Grail's premarket approval application for Galleri, a multi-cancer early detection test. The advisory committee meeting represents a critical regulatory milestone for the company, which anticipates a potential approval decision in early 2027.
Outside advisers to the U.S. Food and Drug Administration narrowly voted to recommend broader access to several unapproved peptides popular in wellness circles, backing a push by HHS Secretary Robert F. Kennedy Jr. despite objections from FDA career scientists about limited safety data and potential conflicts of interest among panelists.
