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 ...

Duchenne muscular dystrophy families are sharing stories about Elevidys complications on social media. But they aren’t ...

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

Nuvation Bio's FDA approval for IBTROZI isn't boosting its stock. Learn about NUVB's financial risks, valuation concerns, and ...

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.

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 ...

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 ...

Breyers is recalling Rocky Road ice cream that was placed in a Chocolate Truffle ice cream packaging, posing a danger to ...

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