FDA approves AstraZeneca’s Imfinzi combo for bladder cancer
The US Food and Drug Administration (FDA) has approved AstraZeneca's human monoclonal antibody Imfinzi (durvalumab) with ...
New FDA commissioner signed off on vaccine chief’s ouster: Reports
Commissioner Marty Makary signed off on the plan to push out the agency’s top vaccine official, Peter Marks, in one of his ...
FDA recall list for March 2025: Tostitos chips, Stouffer’s frozen meals and 11 more items
Frozen meals, snacks, cat food, and cheesecake are just a few items listed in March on the Federal Food and Drug ...
Drugmakers face market turmoil following FDA shakeup and Trump health overhaul
The pharma and biotech sector has been under pressure since Donald Trump returned to the White House earlier this year.
US FDA approves freeze-dried version of Bavarian Nordic's mpox, smallpox vaccine
Denmark's Bavarian Nordic said on Monday the U.S. Food and Drug Administration has approved a freeze-dried formulation of its ...
Drug stocks sink as FDA’s top vaccine official is ousted in Trump overhaul
Shares of U.S. drugmakers fell on Monday after reports that the Food and Drug Administration’s top vaccine official was forced to resign, the most high-profile exit at the regulator as the ...
Top vaccine official resigns from FDA, criticizes RFK Jr. for promoting ‘misinformation and lies’
The top vaccine official with the Food and Drug Administration has resigned and criticized the nation's top health official ...
Medscape1h
FDA Okays Perioperative Durvalumab Regimen for Muscle-Invasive Bladder Cancer
Approval was based on improved survival outcomes vs platinum-based chemotherapy as demonstrated in the phase 3 NIAGARA study.
American Hospital Association12h
FDA recalls Medtronic Aortic Root Cannulas
The Food and Drug Administration has identified a Class I recall of Medtronic Aortic Root Cannulas due to a risk of ...
STAT3d
Two of FDA’s top cancer regulators to depart, heightening worries about drug reviews
Deputy directors at the FDA center that oversees the regulation of cancer drugs plan to leave, adding to a flood of top ...
STAT10h
Texas judge strikes down FDA’s plan to regulate lab-developed tests
The FDA has long believed it has the power to regulate lab-developed tests, but it only put out the rules under former President Biden.
Biotech Investors Rush for the Exits After FDA Official Resigns
Biotech investors are reeling after the sudden departure of Peter Marks, a pivotal figure in the U.S. Food and Drug ...