News

GSK seeks FDA nod for expanded use of RSV vaccine in adults
(Reuters) -British drugmaker GSK said on Monday it had submitted an application to the U.S. Food and Drug Administration to ...
FDA Commissioner: 100 Days of Change—Modernizing the FDA for a Healthier America | Opinion
The Food and Drug Administration (FDA) can maintain its high bar for safety and efficacy, and also cut the waste and ...
FDA Commissioner: ‘We want to focus on food’
Makary, a surgical oncologist tapped by President Trump to serve as the the 27th FDA chief, joined NewsNation on Thursday to ...
STAT6d
Inside the staff exodus and tanking morale that threaten Makary’s FDA
WASHINGTON — The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s ...
US FDA publishes 200 complete response letters from archive in transparency drive
The U.S. Food and Drug Administration on Thursday publicly shared over 200 archived so-called complete response letters ...
Senate panel clears FDA appropriations
Presented by Express Scripts Pharmacy Benefit Services{beacon} Health Care Health Care   The Big Story Senate panel clears ...
Food Safety News3d
FDA administrator declares first 100 days in office a success
To mark his first 100 days as head of the FDA, Martin Makary is touting his efforts to change the agency’s operations. The Food and Drug Administration ...
Independent Journal Review12d
Trump FDA Chief Reportedly Makes End Run Around Career Bureaucrats
Makary and Center for Biologics Evaluation and Research Director Vinay Prasad unveiled a new framework in the New England Journal of Medicine on May 20 requiring a stronger evidence base for boosters ...
Reuters4d
U.S. Food and Drug Administration - Reuters
US FDA declines to approve Ultragenyx's gene therapy for rare genetic disorder The U.S. Food and Drug Administration has declined to approve Ultragenyx Pharmaceutical's experimental gene therapy ...
Food Engineering6d
FDA to Update Standard of Identity for Canned Tuna
The U.S. Food and Drug Administration (FDA) plans to update the standard of identity for canned tuna, as well as its standard ...
FDA Review of Citizen Petition Offers a Fresh Look at NurOwn®'s Evidence of Treatment Effectiveness
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative ...
Food Safety News3d
FDA increases enforcement of regs for imports including seafood, papayas, cantaloupe and more
The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from foreign countries. The agency updates and ...