Four stakeholders comment on an FDA draft guidance on comparability of human cell and gene therapy products and suggest improvements.
AstraZeneca says its Imfinzi failed to achieve statistical significance in the PACIFIC-2 trial in some non-small cell lung cancer patients.
Law firm Cooley adds 14-year FDA lawyer Son Nguyen to the firms Washington, DC office.
Manhattan Institute senior fellow and former FDAer Randall Lutter says there are many things Congress should be doing to alleviate the drug shortage a...
The Reagan-Udall Foundation recommends steps to be taken by FDA and other stakeholders to improve evidence generation in postmarket studies.
House Energy and Commerce Committee Republicans threaten FDA with a subpoena if it continues to delay submitting documents on what they consider risky...
BridgeBio Pharma says it will file by 12/31 an NDA for acoramidis after releasing Phase 3 data from its ATTRibute-CM study of acoramidis in transthyre...
Novo Nordisk says data from its landmark Phase 3 SELECT cardiovascular outcomes trial assessing the effects of once-weekly Wegovy showed that the drug...
