In November 2025, the U.S. Food and Drug Administration (FDA) issued several approvals across oncology and supportive care.
The FDA has approved an adeno-associated virus 9 gene replacement therapy to treat individuals aged 2 years and older with ...
The U.S. Food and Drug Administration has approved Imfinzi (durvalumab) in combination with standard-of-care FLOT ...
The U.S. Food and Drug Administration (FDA) today published more than 200 complete response letters (CRLs) issued between 2002 and 2024. FDA reports that it has only published CRLs sent to companies ...
A top FDA official has proposed broad changes to the review and approval process for vaccines, citing a new internal review linking the deaths of 10 children to COVID-19 vaccines. In an internal memo ...
(NASDAQ: AXGN), a global leader in developing and marketing innovative surgical technologies for the restoration of peripheral nerve function, today announced that the U.S. Food and Drug ...
FDA lowers surveillance requirement to 50 patients from 300 patients in original HDE approval based on assessment of first 21 SAVE Surveillance ...
Pregnant people have a higher risk of severe disease and death from COVID, so making it harder for them to get vaccinated ...
A senior Food and Drug Administration official on Friday said the agency will change its vaccine approval process, alleging ...
Learn why understanding the FDA’s 510(k) database is essential for every MedTech manufacturer. Discover how it supports competitive analysis, regulatory planning, faster approvals, and smarter product ...
Shares of several major vaccine makers lost ground Monday following a report U.S. vaccine approval rules could become ...
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