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RVL Pharmaceuticals asks FDA to take six specific actions for any ANDA or 505(b)(2) application referencing its Upneeq.[ Price : $8.95]
FDA extends to 9/22 the PDUFA action date for an Incyte sNDA for an expanded indication for Jakafi.[ Price : $8.95]
OptiNose asks FDA to require specific steps of any ANDA or section 505(b)(2) applicants referencing the companys Xhance nasal spra...[ Price : $8.95]
FDAs 6/7 accelerated approval for Biogens Alzheimers drug Aduhelm provokes an immediate uproar among stakeholders over whether it ...[ Price : $8.95]
FDA says it is not accepting a Verily Life Sciences letter of intent proposing to use its study watch in a Parkinsons disease eval...[ Price : $8.95]
FDA says Aziyo Biologics is recalling one specific donor lot of its FiberCel Fiber Viable Bone Matrix.[ Price : $8.95]
FDA grants BerGenBio ASA a fast track designation for bemcentinib in combination with an anti-PD-(L)1 agent for treating patients ...[ Price : $8.95]
FDA clears an AngioDynamics 510(k) for the AlphaVac Mechanical Thrombectomy System, an off-circuit, multi-purpose mechanical aspir...