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FDA sets highest risk level for burger recall
A recall of seafood burgers has been updated to the highest risk by the U.S. Food and Drug Administration. Connecticut-based company Caraluzzi’s Markets initiated the recall in April because its Italian Style Seafood Burgers contain undeclared egg, which poses a risk of serious or life-threatening reactions to people with egg allergies.
(Reuters) -Capricor Therapeutics said on Monday the U.S. Food and Drug Administration (FDA) plans to convene a panel of ...
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 ...
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.
The Bagsvaerd, Denmark, company said that if the application is approved, Wegovy would become the first oral formulation of a ...
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