News

Opinion: FDA should judge drugs on what they do in real life, not just in companies’ clinical trials
U nder the new leadership of Marty Makary, the FDA should focus more attention on the critical role of real-world clinical ...
STAT2d
Inside the staff exodus and tanking morale that threaten Makary’s FDA
The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s work, current ...
FDA Prevails in Blue State Suit Over Abortion Pill Safety (2)
The US Food and Drug Administration held off a legal challenge from a coalition of blue states over the abortion pill, ...
STAT9d
Many medical devices deemed ‘breakthrough’ by FDA are backed by patchy evidence
The FDA's breakthrough devices program helps the industry with faster review times, but the benefit to patients is unclear.
MedPage Today13d
Experts Have Questions About FDA's New Priority Review Program
While there's little disagreement that speeding drug approvals would be a good thing, there are more questions than answers ...
RFK Jr.'s FDA officials overrode career staff to limit COVID shots
The FDA's Dr. Vinay Prasad said that he disagreed with the agency's career vaccine reviewers about COVID shot approvals.
pharmaphorum2d
KalVista bags FDA approval for delayed oral HAE drug
KalVista Pharma has finally received FDA approval for its oral kallikrein inhibitor sebetralstat, becoming the first ...
BioSpace9d
FDA’s AI Rollout Raises Questions Around Readiness, Legality
The FDA’s clunky launch of Elsa, an AI tool to increase efficiency, has sparked concern from agency employees and outside ...
A Promising Depression Drug Works. Psychedelics Are Back.
None have been approved by the Food and Drug Administration so far, though in 2019, Johnson & Johnson received FDA permission ...
Fierce Pharma2d
KalVista bounces back from FDA delay with approval for oral rare disease med Ekterly
After facing an unexpected regulatory delay last month, KalVista Pharmaceuticals has leapt into the commercial realm with the ...