Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances on ANDA bioequivalence study designs.
New FDA research on direct-to-consumer television ads finds that disclosures could help viewers in differentiating between progression-free survival a...
Abiomed recalls its Impella 5.5 with SmartAssist catheter, an intravascular micro axial blood pump that supports a patients circulatory system, due to...
The Justice Department resolves civil claims requiring Zoll Medical to pay $400,000 for selling Chinese-made products to the federal government.
FDA grants Genmab an accelerated approval for its BLA for Epkinly (epcoritamab-bysp) injection for treating adult patients with relapsed or refractory...
FDA approves a Krystal Biotech BLA for Vyjuvek, a herpes-simplex virus type 1 vector-based gene therapy for treating wounds in patients older than six...
FDA clears a Beta Bionics 510(k) for its Bionic Pancreas for treating Type 1 diabetes in patients aged six years and older.
Vanda calls on FDA to revoke its approval of an MSN Pharmaceuticals ANDA for generic Hetlioz because it says the ANDA does not demonstrate bioequivale...
