FDA warns Everything Health that its Web site and social media pages are selling unapproved and misbranded new drugs purporting to treat Covid-19.
RVL Pharmaceuticals asks FDA to take six specific actions for any ANDA or 505(b)(2) application referencing its Upneeq.
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...