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...
FDA releases the form FDA-483 issued following an inspection at the Nephron Pharmaceuticals warehouse in Murray, KY.
FDA approves AbbVies Rinvoq (upadacitinib) for treating adults with moderately to severely active Crohns disease.
FDA clears an Abbott 510(k) for its Assert-IQ insertable cardiac monitor for diagnosing and long-term monitoring of people experiencing arrhythmias.
Draeger Medical recalls its Seattle PAP Plus continuous positive airway pressure device and VentStar breathing components due to breathing circuit con...
