Also known as: CDER, FDA Center for Drug Evaluation and Research
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FDA released its 2026 Rare Disease Hub Strategic Agenda and a draft guidance on 3-year New Clinical Investigation Exclusivity.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.
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.
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.
The FDA has released draft guidance to help drug developers validate New Approach Methodologies as alternatives to animal testing, establishing four validation pillars and signaling a shift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.
The FDA has released draft guidance to help drug developers validate new approach methodologies as alternatives to animal testing, marking a milestone in the agency's roadmap to reduce reliance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.
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.
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.
The FDA issued draft guidance establishing a plausible mechanism framework for approving individualized therapies targeting ultra-rare diseases when randomized controlled trials are not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.
