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, ...
FDA announces a 9/17 virtual public workshop entitled Spinal Device Clinical Review.