By Padmanabhan Ananthan Feb 2 (Reuters) - Aquestive Therapeutics said on Monday the U.S. FDA has declined to approve its oral ...
By Ahmed Aboulenein WASHINGTON, Feb 1 (Reuters) - The U.S. Food and Drug Administration on Sunday began accepting requests to ...
FDA’s new PreCheck pilot streamlines building US pharma manufacturing plants with earlier guidance and faster reviews. Read more here.
Jan 28 (Reuters) - Regenxbio said on Wednesday the U.S. Food and Drug Administration has placed a clinical hold on two of its ...
Jan 19 () - Pharmaceutical company Boehringer Ingelheim said on Monday the U. Food and Drug Administration had approved its ...
The FDA launched PreCheck pilot program to strengthen U.S. drug supply chain by improving regulatory predictability.
In January, the FDA released its 2026 Priority Deliverables for its Human Foods Program (HFP), which oversees all food safety ...
The U.S. Food and Drug Administration (FDA) is celebrating a historic milestone in 2026, marking 120 years of national ...
In a series of high-impact moves, the FDA is reshaping how it approves and regulates drugs, including accelerating reviews, revising vaccine standards and simplifying biosimilar development.
Dec 9 (Reuters) - U.S. health regulators informed senior executives at Merck, Sanofi and AstraZeneca last week that their approved protective RSV treatments for infants would face fresh safety ...
The US Food and Drug Administration intends to put a “black box” warning on Covid-19 vaccines, according to two people familiar with the agency’s plans, the latest move by President Donald Trump’s ...
The U.S. FDA approved 27 drugs in December, the highest month of 2025. This compares to 18 approvals in November and brings ...
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