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).
FDA releases its latest batch of Warning Letters that include Evolved Ayurvedic Discoveries and AcelRx Pharmaceuticals.
FDA approves a Shockwave Medical PMA for its Intravascular Lithotripsy to treat severely calcified coronary artery disease.
Federal Register notice: FDA has announced a 3/24 joint meeting of the Arthritis and the Drug Safety and Risk Management Advisory Committees to discus...