Former Becton Dickinson medical director Hooman Noorchashm petitions FDA to warn patients about the unknown and inadequately studied effect of FDA-reg...
FDA asks the Oncologic Drugs Advisory Committee whether Acrotech Biopharmas plan to complete a confirmatory trial for two cancer drugs years after the...
Cardinal Health recalls its latest version (6/2023) of its Monoject syringes branded as Cardinal Health Monoject syringes because their dimensions dif...
Four stakeholders comment on an FDA draft guidance on comparability of human cell and gene therapy products and suggest improvements.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.
