Here's How Trump's Pick To Lead The FDA Can Supercharge The Agency
The U.S. Senate last week confirmed former Johns Hopkins surgeon and professor Dr. Marty Makary to lead the Food and Drug ...
Fierce Pharma2d
FDA staff cuts could disrupt drug reviews, putting agency's critical funding programs at risk: reports
Massive cuts at the FDA have hit staff tied to drug reviews and user fees, putting future approvals in jeopardy, according to ...
Axios on MSN3d
Drug industry worries about FDA delays
Pharmaceutical companies are growing increasingly concerned widespread cuts at the Food and Drug Administration could set the ...
Compound versions of some weight loss drugs to be restricted
Zepbound contains the same active ingredient, tirzepatide, as Mounjaro, which is also made by Lilly and is FDA-approved to ...
FDA delays full approval of Novavax Covid-19 vaccine even though it was on track for clearance
The US Food and Drug Administration has delayed granting full approval of Novavax’s Covid-19 vaccine despite it being on ...
techtimes25d
Beating FDA Delays: The Compliance Strategy Saving Pharma Millions
The Food and Drug ... FDA standards—challenges that can mean the difference between stalled approval and swift market entry. Gaurang's precision-driven strategy cuts approval timelines ...
Fierce Biotech5d
Federal judge blocks FDA's regulation of lab-developed tests
A federal judge in Texas has blocked the FDA’s plans to bring laboratory-developed tests under the same regulations it uses ...
Pharm Exec27d
FDA’s New Accelerated Approval Draft Guidance
The FDA’s latest ... Accelerated Approval of Drugs and Biologics,” is a game-changer for biopharmaceutical companies hoping to bring life-saving treatments to market. If you’re navigating the ...
KETV Omaha3d
FDA delays full approval of Novavax COVID-19 vaccine even though it was on track for clearance
The U.S. Food and Drug Administration has delayed granting full approval of Novavax's ... A spokesman for HHS told CNN, "The FDA's independent review process for the Novavax vaccine, like all ...