Three stakeholders ask FDA to consider making specific revisions to its draft guidance on new safety labeling change provisions in the Federal Food, D...
Sens. Chris Coons and Ted Budd introduce legislation to promote improvements in U.S. biopharmaceutical manufacturing through a new Center of Excellenc...
FDA launches a new meeting minutes pilot program aimed at reducing delays and confusion that often follow formal meetings between the agency and drug ...
Siemens Healthineers issues an urgent safety correction (Class 1 recall) for dozens of its 3 Tesla MRI models after identifying a potentially catastro...
Aesculap Implant Systems agrees to pay $38.5 million to resolve federal allegations under the False Claims Act that it knowingly sold defective knee r...
A business TV station in India says two persons have been arrested for impersonating FDA officials and attempting to extort Hetero Drugs.
FDA approves Genmabs Epkinly (epcoritamab-bysp) for combination with lenalidomide and rituximab in adults with relapsed or refractory follicular lymph...
FDA warns Noblesville, IN-based Verdure Sciences about failing to submit an IND for a clinical study of its investigational drug Maplifa.
