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Federal Register notice: FDA makes available draft guidance #276 entitled Effectiveness of Anthelmintics: Specific Recommendations for Products Propos...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...
Merck sues Johns Hopkins University in Maryland federal court over patents Hopkins obtained following a research collaboration with Merck using Keytru...
