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 ...
Medical Device Network5m
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).
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 ...
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 ...
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 ...
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 ...
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. ...
FDA launches program to encourage American drug manufacturing
The U.S. Food and Drug Administration announced Thursday it is launching "FDA PreCheck" in order to help construct drug ...
Applied Clinical Trials Online57m
Rethinking the Value of FDA Breakthrough Designation
In this video interview, Meri Beckwith, Co-CEO of Lindus Health, examines how recent developments with Complete Response ...