On October 3, 2025, the U.S. Food and Drug Administration (FDA) unveiled a pilot prioritization program that provides for accelerated review of abbreviated new drug applications (ANDAs) for generic ...
A plan to slash Food and Drug Administration drug review times is raising alarms at the public health agency that's been ...
A gene therapy for hearing loss. A drug that helps people quit e-cigarettes or vaping. An anesthetic whose main ingredient will be manufactured in the U.S. These are among the first nine therapies ...
Two members of Congress launched an investigation into FDA Commissioner Marty Makary, MD, MPH, and his use of "priority vouchers" for expedited drug approvals, suggesting that the voucher program ...
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 ...
Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53. WASHINGTON — A new program ...
By Maggie Fick and Patrick Wingrove SAN FRANCISCO, Jan 16 (Reuters) - More than half a dozen major drugmakers are participating in the Trump administration's speedier review program for new medicines, ...
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