News

GSK's antibiotic gets FDA priority review for oral treatment of gonorrhoea
(Reuters) -British drugmaker GSK said on Monday that the U.S. Food and Drug Administration has accepted its application for ...
FDA regulator reinstalled less than two weeks after White House ouster
Vinay Prasad, the FDA’s top vaccine and gene therapy regulator, was the target of a right-wing pressure campaign over his ...
Pharmaceutical Technology6m
GSK’s oral antibiotic for gonorrhoea set for FDA review
A new pill that combats antibiotic-resistant strains of gonorrhoea is closer to US approval, after the FDA accepted GSK’s gepotidacin for priority review.
Amphastar Announces FDA Approval for Iron Sucrose Injection, USP
According to the FDA, Amphastar's iron sucrose injection meets the criteria for bioequivalence and therapeutic equivalence to ...
Medical Device Network2m
FDA approves Nyxoah’s Genio system for obstructive sleep apnoea
The US FDA has granted approval to Nyxoah’s Genio system for treating individuals with moderate to severe obstructive sleep apnoea (OSA).
Pharmaceutical Technology40m
Boehringer’s Hernexeos receives fast-tracked FDA approval
Boehringer's Hernexeos is now FDA-approved for patients with HER2-positive NSCLC, bringing it into direct competition with ADC Enhertu.
Fierce Pharma1d
Vinay Prasad is back at the FDA after last month's surprise ouster. Will he stay this time?
Vinay Prasad, M.D., has rejoined the FDA, the latest turn in a monthslong stretch of leadership turnover at the agency. | “At ...
A former FDA chief’s ‘brilliant’ move to test the agency’s commitment to making America healthy
The former head of the US Food and Drug Administration is testing the Trump administration’s commitment to “Make America ...
STAT2d
In internal FDA town hall, employees raise concerns about staffing, impromptu expert meetings
Exclusive: FDA employees, in a town hall after the ouster of Vinay Prasad, asked about unusual meetings and staff shortages. ...
Laura Loomer Blasts Return of FDA Vaccine Chief She Helped Force Out
Loomer is an influential figure in right-wing circles. She was present alongside Trump on the 2024 campaign trail, and she ...
Your orange juice may soon have a little less sugar, if FDA rule is enacted
Orange juice has been criticized for its sugar content, and possible regulations could lower the levels. Experts share their ...