The Food and Drug Administration is announcing the first round of drugs that will receive drastically expedited reviews at ...

The U.S. Food and Drug Administration has approved Amgen and AstraZeneca's drug for a type of chronic inflammatory sinus ...

FDA announced the first nine recipients of priority review vouchers, which offers expedited drug review to products aligned ...

A gene therapy from Regeneron, a pancreatic cancer medicine from Revolution Medicines and a porphyria drug from Disc Medicine ...

The FDA's rejections of Replimune and Capricor therapies show how instability threatens biotech innovation, CEOs say.

A group of GOP senators is calling on Food and Drug Administration (FDA) Commissioner Marty Makary to provide answers about ...

Under the Trump administration, the Department of Health and Human Services and the Food and Drug Administration have been ...

As part of the FDA's rolling review of the biologics license application, Vertex expects to submit the first module to the regulator for potential accelerated approval before the end of 2025, and said ...

Pfizer Chief Executive Officer Albert Bourla said that vaccines are harder to get approved right now as Health Secretary ...

Women seeking fertility treatment are getting financial relief after the Trump administration reached a deal ...

Here are today’s top U.S. food recall / outbreak alerts. Some of these may have been reported earlier but are still "live" ...

President Trump announced a pair of efforts Thursday aimed at expanding access to in vitro fertilization (IVF) as he seeks to ...