FDA warns Milford, DE-based Tesla BioHealing about illegally marketing adulterated and misbranded medical devices.
Janssen Pharmaceutical files a supplemental NDA that is seeking to convert Balversas (erdafitinib) 2019 accelerated approval to full approval for trea...
FDA approves a Bristol Myers Squibb BLA supplement for Reblozyl (luspatercept-aamt) for treating anemia in patients with very low- to intermediate-ris...
Two SheppardMullin attorneys say the second Warning Letter issued this year by the CDER Office of Prescription Drug Promotion shows the agency is clos...
A bipartisan group of nine members of Congress from Georgia calls for greater FDA transparency on efforts to resolve the current shortage of chemother...
FDA researchers say the agency is working collaboratively to find innovative approaches to optimizing dosages of cancer drugs.
Texas approves a bill to create a program to import drugs from Canada pending HHS approval.
Senator Elizabeth Warren (D-MA) and Rep. Pramila Jayapal (D-WA) urge FDA commissioner Robert Califf to restrict patents that are listed in the Orange ...
