[ Price : $8.95]
Four stakeholders comment on an FDA draft guidance on comparability of human cell and gene therapy products and suggest improvemen...[ Price : $8.95]
AstraZeneca says its Imfinzi failed to achieve statistical significance in the PACIFIC-2 trial in some non-small cell lung cancer ...[ Price : $8.95]
Law firm Cooley adds 14-year FDA lawyer Son Nguyen to the firms Washington, DC office.[ Price : $8.95]
Manhattan Institute senior fellow and former FDAer Randall Lutter says there are many things Congress should be doing to alleviate...[ Price : $8.95]
The Reagan-Udall Foundation recommends steps to be taken by FDA and other stakeholders to improve evidence generation in postmarke...[ Price : $8.95]
House Energy and Commerce Committee Republicans threaten FDA with a subpoena if it continues to delay submitting documents on what...[ Price : $8.95]
BridgeBio Pharma says it will file by 12/31 an NDA for acoramidis after releasing Phase 3 data from its ATTRibute-CM study of acor...[ Price : $8.95]
Novo Nordisk says data from its landmark Phase 3 SELECT cardiovascular outcomes trial assessing the effects of once-weekly Wegovy ...