News

Capricor Therapeutics said on Monday the U.S. Food and Drug Administration (FDA) plans to convene a panel of outside experts ...
From STAT’s Adam Feuerstein: The FDA informed Capricor Therapeutics that a meeting of outside experts will be convened to ...
The FDA has rehired at least some workers tasked with releasing public records generated by the agency’s regulatory ...
The FDA’s user free programs account for just under half of the agency’s budget—money that could be imperiled by the recent ...
Under the current expiring user fee agreements, the FDA commits to complete new drug approval reviews within either 10 months ...
Multiple current and laid-off FDA employees said the abrupt layoffs had resulted in delays and disruptions to the agency's ...
"I have tremendous confidence in the many scientists, inspectors, and staff at the FDA to help accomplish these goals and am excited to work with them," said new FDA commissioner Dr Marty Makary.
The Bagsvaerd, Denmark, company said that if the application is approved, Wegovy would become the first oral formulation of a ...