The Justice Department says sports supplement company owner Brian Parks was sentenced to time in prison and forfeited $350,000 for distributing unappr...
Attorney Matthew Decker outlines five key provisions of an FDA action plan on the regulation of artificial intelligence and machine learning-based sof...
FDA accepts for priority review an Amgen NDA for sotorasib for treating certain patients with KRAS G12C-mutated locally advanced or metastatic non-sma...
FDA acting commissioner Janet Woodcock defends the integrity of the agencys drug review processes and rejects a Public Citizen proposal for a firewall...
FDA accepts for priority review an Amgen NDA for sotorasib for treating certain patients with KRAS G12C-mutated locally advanced or metastatic non-sma...
Verrica Pharmaceuticals resubmits its NDA for VP-102 (cantharidin 0.7% topical solution), a proprietary topical therapy for treating molluscum contagi...
FDA approves an Axonics Modulation Technologies PMA for its third-generation implantable neurostimulator.
FDA accepts for review a Coherus BioSciences BLA for CHS-1420, a biosimilar to AbbVies Humira (adalimumab).