Regeneron Pharmaceuticals has won FDA accelerated approval of its Lynozyfic treatment for certain patients with the blood ...

Breaking down what patients should know about each FDA therapeutic approval from June 2025 across various oncology ...

A combination featuring Exelixis’ experimental drug zanzalintinib has beaten Bayer’s gastrointestinal cancer med Stivarga in a phase 3 trial. The overall survival win moves Exelixis a step closer to ...

FDA Approves Yeztugo as First Twice-Yearly Injectable HIV Prevention Option in the U.S. Clinical Trials Show Near-Perfect ...

A drug with the potential to drastically curb the HIV epidemic just cleared its first regulatory hurdle. On Wednesday, the Food and Drug Administration approved lenacapavir for the prevention of HIV.

A drug with the potential to drastically curb the HIV epidemic just cleared its first regulatory hurdle. On Wednesday, the Food and Drug Administration approved lenacapavir for the prevention of HIV.

WASHINGTON — The US has approved the world’s only twice-a-year shot to prevent HIV, maker Gilead Sciences announced Wednesday. It’s the first step in an anticipated global rollout that could ...

FDA's long-standing accelerated approval program generally issues decisions in six months for drugs that treat life-threatening diseases. Regular drug reviews take about 10 months.

FDA's long-standing accelerated approval program generally issues decisions in six months for drugs that treat life-threatening diseases. Regular drug reviews take about 10 months.