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.
GSK says its PD-1 inhibitor Jemperli (dostarlimab) achieved the primary endpoint in a registrational Phase 2 trial in patients with mismatch repair-de...
FDA releases a draft guidance detailing its current recommendations for developing psychedelic drug products, providing sponsors with the agency's mos...
FDA approves a new subcutaneous dosing regimen for Eisai's Alzheimer's disease therapy Leqembi (lecanemab-irmb), allowing patients to begin treatment ...
The agency posts a final guidance that provides recommendations for formal meetings between the agency and sponsors or requestors developing over-the-...
