On Tuesday, the U.S. Food and Drug Administration announced a new initiative to offer expedited reviews for new medicines, an ...

Shares of Gilead Sciences (NASDAQ:GILD) reached a session high on Wednesday after the U.S. Food and Drug Administration (FDA) ...

The Saudi Food and Drug Authority (SFDA) has announced the implementation of new technical regulations for food effective ...

We are pleased to receive fast track designation from the FDA in recognition of the MELAS community’s unmet medical needs and ...

The Commissioner’s National Priority Voucher can be used by drug developers to participate in a novel priority program for ...

The FDA has approved tafasitamab in combination with lenalidomide and rituximab for adults with relapsed/refractory ...

All the figurative FDA trains are running on time, according to the agency’s leader Marty Makary, M.D. | “I'm proud to report ...

CSL Behring’s Andembry is now approved as a subcutaneous, self-injection for hereditary angioedema (HAE) patients ages 12 and older and will be available by the end of June 2025.

The Food and Drug Administration (FDA) has approved Andembry ® (garadacimab-gxii) for prophylactic use to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years ...

Under the new initiative, companies may receive a voucher enabling FDA review to be shortened from the standard 10–12 months to just 1–2 months following final application submission if the drug ...

The recall was initiated after routine sampling revealed that the product contained sulfites not disclosed on the packaging ...