Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. The biggest ...

・The timeline extension comes on the heels of the FDA requesting additional information to assess Filspari’s clinical benefit. ・The company submitted responses and the agency determined that the ...

In guidance released Monday, the US Food and Drug Administration (FDA) provides the timelines it will stick to when reviewing responses to complete response letters (CRLs) for drugs and biologics when ...

(RTTNews) - Denali Therapeutics Inc. (DNLI) on Monday announced that the U.S. Food and Drug Administration has extended its review timeline of the company's investigational therapeutic Tividenofusp ...

The U.S. Department of Health and Human Services and the U.S. Food and Drug Administration have released further details of their plans to remove all petroleum-based synthetic dyes from the nation's ...

The Pulse Report highlights AI's expanding role in drug discovery, biomarker identification, clinical trial optimization and regulatory decision support, helping pharmaceutical companies reduce ...

Marty Makary resigned as FDA commissioner amid controversy. But his reforms to drug review times and AI are the agency's ...