The Health and Human Services Office of Inspector General has found that, in a few cases, FDA officials veered from the accelerated approval pathway.

The review, which was spurred by controversy over the FDA's Aduhelm approval, recommends two main changes in agency procedures.

The OIG report points to gaps in documentation and decision-making transparency, particularly in the case of Aduhelm, where FDA records indicated only 13 meetings with Biogen, but congressional ...

Ozempic, the blockbuster GLP-1 drug that was originally approved to treat type 2 diabetes, has now also been approved by the ...

Approvals for drugs from Biogen Inc. and Sarepta Therapeutics Inc. show flaws in the process US drug regulators use to speed ...

A report from the U.S. FDA's Office of Inspector General is calling into question the thoroughness of the agency's accelerated approval process, and is using treatments from Sarepta Therapeutics ...

Robert F. Kennedy Jr. may soon be America's top pharmaceutical regulator. That is cause for concern in Seattle’s biotech ...

An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, ...

People with treatment-resistant depression can now take Spravato's ketamine-derived nasal spray as a standalone treatment.

A Food and Drug Administration project to promote diversity in clinical studies of cancer treatments was removed from the ...

Joel Stanley, the founder and former CEO of Charlotte’s Web, is leading an effort to achieve approval from the FDA for a novel treatment to treat autism spectrum ...

Federal regulators have warned a Waco company that its human amniotic products are “unlicensed” and “unapproved,” and that ...