A bipartisan Senate letter urges FDA commissioner Robert Califf and HHS secretary Xavier Becerra to step up efforts to help resolve amoxicillin and ot...
FDA grants one part and denies another part of a petition submitted by the Microbiome Therapeutic Innovation Group by publishing a final policy on fec...
FDA accepts for priority review a Regeneron Pharmaceuticals supplemental BLA for Evkeeza (evinacumab-dgnb) as an adjunct to other lipid-lowering thera...
Federal Register notice: FDA requests nominations for voting members to serve on CDRHs Technical Electronic Product Radiation Safety Standards Committ...
Federal Register notice: FDA makes available draft guidance #276 entitled Effectiveness of Anthelmintics: Specific Recommendations for Products Propos...
The Justice Department says the two owners of New Jersey-based Synergy Medical have admitted to participating in a conspiracy to commit healthcare fra...
The heads of two cancer advocacy organizations urge Congress to approve the VALID Act to regulate laboratory-developed tests offered without assurance...
Janssen files a patent infringement suit against Amgen and its plans to seek FDA approval and market a biosimilar copy of Janssens blockbuster Stelara...
