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May 17, 2026
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.
Jul 15, 2026
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 A draft guidance covers individualized therapies.
Jun 23, 2026
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.
Aug 06, 2026
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.
Jul 24, 2026
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.
May 15, 2026
The FDA's January draft guidance proposes MRD-negative complete response as an accelerated approval end point for multiple myeloma drugs.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.
Jul 23, 2026
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.
May 11, 2026
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.
May 05, 2026
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.
May 02, 2026
FDA released its 2026 Rare Disease Hub Strategic Agenda and a draft guidance on 3-year New Clinical Investigation Exclusivity.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.
Apr 14, 2026
The US Food and Drug Administration sent messages on 30 March to more than 2,200 companies and researchers tied to over 3,000 clinical trials over missing ClinicalTrials.gov results. The agency said 29.6% of studies highly likely to be subject to mandatory reporting had no results information submitted.
Apr 06, 2026
NRx Pharmaceuticals said an FDA Type C meeting indicated a path to an NDA for NRX-100, using clinical trial results and real-world ketamine data from more than 65,000 patients.
Mar 20, 2026
The FDA has released draft guidance to help drug developers validate New Approach Methodologies as alternatives to animal testing, establishing four validation pillars and signaling a shift toward human-centric safety data in drug development.
Mar 19, 2026
The FDA has released draft guidance to help drug developers validate new approach methodologies as alternatives to animal testing, marking a milestone in the agency's roadmap to reduce reliance on animal studies in drug development.
Mar 11, 2026
The FDA has established a "plausible mechanism pathway" to approve personalized genome editing and RNA-based therapies for rare and ultra-rare diseases without requiring large randomized controlled trials, streamlining access to individualized treatments.
Feb 28, 2026
NRx Pharmaceuticals completed an in-person FDA Type C meeting regarding NRX-100, a preservative-free ketamine formulation for suicidal depression. The company received guidance on a path to file a New Drug Application based on existing trial data and Real World Evidence from over 65,000 patients.
Feb 24, 2026
The FDA issued draft guidance establishing a plausible mechanism framework for approving individualized therapies targeting ultra-rare diseases when randomized controlled trials are not feasible due to small patient populations.
Feb 24, 2026
The FDA released draft guidance establishing a new approval framework for individualized gene-editing and RNA-based therapies targeting ultra-rare diseases, allowing approvals based on small studies when traditional trials are not feasible.
Feb 19, 2026
The FDA will host Rare Disease Day 2026 on February 23, focusing on patient engagement and accelerating treatment development. The agency released its 2026 Strategic Agenda for the Rare Disease Hub, outlining new regulatory pathways and coordination efforts.
Feb 17, 2026
Cyclerion Therapeutics received positive FDA feedback on its Phase 2 study design for CYC-126, an anesthetic-based therapy with real-time EEG monitoring for treatment-resistant depression, with study initiation planned for second half of 2026.
