FDA extends to 9/22 the PDUFA action date for an Incyte sNDA for an expanded indication for Jakafi.
OptiNose asks FDA to require specific steps of any ANDA or section 505(b)(2) applicants referencing the companys Xhance nasal spray.
FDAs 6/7 accelerated approval for Biogens Alzheimers drug Aduhelm provokes an immediate uproar among stakeholders over whether it undermines the agenc...
FDA says it is not accepting a Verily Life Sciences letter of intent proposing to use its study watch in a Parkinsons disease evaluation.
FDA says Aziyo Biologics is recalling one specific donor lot of its FiberCel Fiber Viable Bone Matrix.
FDA grants BerGenBio ASA a fast track designation for bemcentinib in combination with an anti-PD-(L)1 agent for treating patients with AXL-positive ad...
FDA clears an AngioDynamics 510(k) for the AlphaVac Mechanical Thrombectomy System, an off-circuit, multi-purpose mechanical aspiration thrombectomy d...
Federal Register notice: FDA determines that Hospiras Quelicin Preservative Free (succinylcholine chloride) injection, 20mg/mL, 50mg/mL and 100mg/mL, ...