WASHINGTON (AP) — The Food and Drug Administration commissioner’s effort to drastically shorten the review of drugs favored by President Donald Trump’s administration is causing alarm across the ...

Orthopedics was the most active area over the second half of calendar 2025, with the FDA issuing 13 breakthrough designations to devices in the therapeutic area.

WASHINGTON (AP) — The Food and Drug Administration commissioner’s effort to drastically shorten the review of drugs favored by President Donald Trump’s administration is causing alarm across the ...

WASHINGTON (AP) — The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald Trump's administration is causing alarm across the ...

FDA vouchers are normally a coveted prize for biopharma companies, but a surprise rejection for Disc Medicine’s rare disease drug has biopharma reconsidering.

A Democratic lawmaker is raising new concerns about a Food and Drug Administration program designed to drastically shorten the review of certain drugs, including whether senior officials involved in ...

Big pharmaceutical companies are boosting their production capacity of branded medications with billions of dollars in new U.S. manufacturing plant construction, but generic drug production still ...

The US Food and Drug Administration (FDA) has granted marketing clearance to Eyonis LCS, an artificial intelligence-powered ...