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

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

The FDA's breakthrough devices program helps the industry with faster review times, but the benefit to patients is unclear.

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

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

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 ...

The FDA has removed the REMS program requirement for currently approved BCMA- and CD19-directed autologous CAR T-cell therapies.

An FDA pilot program, known as the Commissioner’s Priority Voucher program, could drastically change the way pharmaceutical ...

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 ...

Following reports of suspicious importation activities like concealment of agricultural commodities under the guise of processed food items, the Food and Drug Administration (FDA) together with the ...

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

San Francisco-based Wildtype, a startup that is pioneering cell-grown salmon, cleared a U.S. Food and Drug Administration ...