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...
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FDA releases a draft guidance detailing its current recommendations for developing psychedelic drug products, providing sponsors with the agency's mos...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 ...
FDA finalizes updated guidance for industry outlining current recommendations for demonstrating bioequivalence of generic topical dermatologic cortico...
