FDA warns Guyer Institute of Molecular Medicine about CGMP and other violations in its production of compounded drugs.
Pfizer says it will submit new data for its Covid-19 oral antiviral Paxlovid (ritonavir) that showed the drug significantly reduced hospitalization an...
Reps. Upton and DeGette introduce their bipartisan Cures 2.0 legislation to create an Advanced Research Projects Agency-Health to work on cures and tr...
PhRMA and Deloitte release a report with strategies for increasing clinical trial diversity.
Federal Register notice: FDA issues an order granting special termination of the debarment involving Sanyasi Raju Kalidindi.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Deciphera Pharmaceuticals Qinlock (ripretinib),...
FDA issues a close-out letter citing resolved GMP issues at Zhejiang Huahai Pharmaceutical Co., Zhejiang, China, an active pharmaceutical ingredient m...
HHS withdraws a Trump Administration policy that directed FDA not to enforce premarket review requirements for laboratory developed tests.