FDA converts the accelerated approval of Eli Lilly's Retevmo (selpercatinib) into a traditional approval for treating adult and pediatric patients wit...
FDA warns South El Monte, CA-based International Medication Systems about CGMP violations in its production of finished drugs.
FDA warns Pleasant Hill, CA-based ZIIP Inc. about Quality System violations in its production of adulterated and misbranded unapproved medical devices...
Biogen executives attempt to reassure investors Tuesday that its experimental anti-tau Alzheimer's disease therapy remains a promising late-stage cand...
FDA finalizes updated guidance for industry outlining current recommendations for demonstrating bioequivalence of generic topical dermatologic cortico...
The House Energy and Commerce Subcommittee on Health plans a hearing 7/15 to examine how FDA can help strengthen U.S. leadership in biomedical innovat...
DTC Perspectives CEO Bob Ehrlich warns that an upcoming FDA proposal to eliminate the adequate provision standard could amount to a de facto ban on br...
Ascelia Pharma pushes back against FDA's recent public release of a Complete Response Letter for its MRI contrast agent Orviglance.
