FDA asks the Gastrointestinal Drugs Advisory Committee whether it recommends approval of Intercepts obeticholic acid to treat pre-cirrhotic liver fibr...
A bipartisan group of members of Congress introduce legislation to redirect penalties paid by drug, cosmetic, supplement, and medical device companies...
FDA commissioner Robert Califf tells the Food and Law Institutes annual meeting that the U.S. could be on the verge of seeing major impacts from new d...
The American Economic Liberties Project and the Initiative for Medicine, Access, and Knowledge recommend policy changes to curb drug company patent ab...
UCB petitions FDA not to approve an Apotex ANDA for generic Fintepla unless its labeling includes specified information from the reference-listed drug...
FDA accepts for priority review a Takeda BLA for TAK-755, an enzyme replacement therapy for treating congenital thrombotic thrombocytopenic purpura.
Prothena says it has appointed former CDER Office of Neuroscience director Billy Dunn to its board of directors.
An attorney who works for a company regulated by FDA asks the DC federal court to stop the agency from publishing the attorneys name and identifying i...
