Also known as: CDER, FDA Center for Drug Evaluation and Research
FDA approved Orzeyful (oveporexton), the first drug to target the underlying loss of orexin signaling in narcolepsy type 1. In two 12-week trials, the twice-daily tablet improved wakefulness and reduced cataplexy versus placebo.
The FDA launched two pilots to boost domestic manufacturing: PreCheck selected seven companies for earlier engagement, and a CVM pilot prioritizes animal drug applications with US-made ingredients.
The FDA has alerted medical device manufacturers that the nitrosamine impurity MNP was detected in certain combination products containing rifampin. The agency outlined manufacturer responsibilities for assessing and controlling nitrosamine risks and highlighted available guidance documents.
The FDA now defaults to a single pivotal trial for drug approvals, replacing the two-trial standard. Critics warn it could approve ineffective drugs. A draft guidance covers individualized therapies.
FDA Commissioner Marty Makary resigned on May 12, 2026, after a 13-month tenure, leaving many informal policy initiatives vulnerable to reversal. Acting Commissioner Kyle Diamantas now leads the agency amid leadership turnover and industry calls for stability.
Tracy Beth Hoeg, the FDA's acting drug center director, has been removed from her role after leading reviews of antidepressants, COVID-19 vaccines and RSV drugs. She is replaced by Dr. Mike Davis, as the agency continues a leadership shake-up.
The FDA's January draft guidance proposes MRD-negative complete response as an accelerated approval end point for multiple myeloma drugs. It defines MRD negativity, sets trial design requirements, and accepts comments through March 23, 2026. Expert Nicholas Richardson discusses calibration challenges and the single-trial model.
Tracy Beth Høeg said in her first address to staff that she will scrutinize antidepressants and RSV products used to protect babies. She said she is prioritizing the health of women and babies.
The global antibody drug conjugate market is calculated at USD 14.76 billion in 2026 and is expected to reach USD 32.66 billion by 2035. North America held a 53% share in 2025, while Asia Pacific is projected to grow fastest.
FDA released its 2026 Rare Disease Hub Strategic Agenda and a draft guidance on 3-year New Clinical Investigation Exclusivity. The agency also outlined new pathways including the plausible mechanism pathway and Rare Disease Evidence Principles to accelerate treatments for rare diseases.
