Biogen Inc. raised its full-year financial guidance as growing sales of its Alzheimer’s drug helped the biotech company beat ...

The new guidelines aim to streamline India’s drug approvals, improve transparency, and align regulatory practices with global ...

Pfizer CEO Albert Bourla is expected at a pro-Trump fundraiser on Friday, sources told CBS News, one day after the president ...

In a 51–47 vote along party lines, the Senate confirmed Monarez as the director of the Centers for Disease Control and ...

WuXi XDC cited strong demand for antibody-drug conjugates, which are widely used in targeted cancer treatments, and for ...

On July 2, linvoseltamab-gcpt (Lynozyfic; Regeneron) received an accelerated approval from the FDA in relapsed/refractory ...

Among 24 such systems (called devices in FDA parlance) authorized since 2015, FDA summaries for 14 lacked data on the ...

Speakers at a congressional briefing on July 22 called on the FDA to take action against the marketing and distribution of ...

The Food and Drug Administration July 31 announced that it is requiring safety label changes to all opioid pain medications ...

Human Foods Program Guidance Agenda for 2025 does not include an updated version of the Agency’s Guidance for Industry: Preparation of Premarket Submissions for Food Contact Substances (Chemistry ...

In recent months, U.S. Food and Drug Administration Commissioner Dr. Marty Makary has amplified unfounded concerns about the ...