The Food and Drug Administration (FDA) said Tuesday they are still processing the approval of vaccines intended to counter ...

The U.S. Food and Drug Administration has approved GSK's autoinjector of Benlysta (belimumab) for subcutaneous injection in ...

The U.S. Food and Drug Administration said on Monday it is revising the labeling of all extended-release stimulants used to ...

These recent food recalls involve cream cheese, eggs, shrimp, and ice cream due to serious health risks including salmonella ...

Health Secretary Teodoro Herbosa says that the seized shipments of goods at the Port Area at the Bureau of Customs on July 1, ...

The elimination of 3,500 full-time employees at the FDA risks undermining the very innovation and domestic capacity the ...

Hemispherian AS, a pioneering biotech company developing next-generation therapeutics for aggressive cancers, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug ...

Sabores Fit Bakery recalled a variety of its mousse desserts on June 20 because of the undeclared presence of allergens.

The FDA has published its proposed agenda for 2025 guidance, including new topics such as food colorings. Topics on the agenda are a priority for the Food and Drug Administration’s Human Foods Program ...

Previously, due to the risk of cytokine release syndrome and neurological toxicities, many CAR T-cell therapies included a REMS requirement.

Qualifying manufacturers will be able to submit some data while clinical trials are ongoing. Marty Makary is the commissioner ...

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...