News

Capricor Therapeutics said on Monday the U.S. Food and Drug Administration (FDA) plans to convene a panel of outside experts ...
The FDA has rehired at least some workers tasked with releasing public records generated by the agency's regulatory ...
From STAT’s Adam Feuerstein: The FDA informed Capricor Therapeutics that a meeting of outside experts will be convened to ...
The FDA’s user free programs account for just under half of the agency’s budget—money that could be imperiled by the recent ...
The FDA has approved a dihydroergotamine-based nasal powder for the acute treatment of migraine with or without aura in ...
Under the current expiring user fee agreements, the FDA commits to complete new drug approval reviews within either 10 months ...
Shares of ImmunityBio touched a 52-week low after the company received a refusal-to-file letter from the Food and Drug Administration for a supplemental biologics license application for ...
"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.