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RVL Pharmaceuticals Wants Upneeq Equivalence Requirements

[ Price : $8.95]

RVL Pharmaceuticals asks FDA to take six specific actions for any ANDA or 505(b)(2) application referencing its Upneeq.

FDA Extends Jakafi sNDA Review Time

[ Price : $8.95]

FDA extends to 9/22 the PDUFA action date for an Incyte sNDA for an expanded indication for Jakafi.

OptiNose Wants Xhance Bioequivalence Restrictions

[ 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...

Uproar Greets FDAs Aduhelm OK for Alzheimers

[ Price : $8.95]

FDAs 6/7 accelerated approval for Biogens Alzheimers drug Aduhelm provokes an immediate uproar among stakeholders over whether it ...

FDA Rejects Verily Parkinsons Letter of Intent

[ 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...

Aziyo Biologics Recalls 1 Lot of FiberCel

[ Price : $8.95]

FDA says Aziyo Biologics is recalling one specific donor lot of its FiberCel Fiber Viable Bone Matrix.

Fast Track for BerGenBio Lung Cancer Therapy

[ 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 ...

FDA Clears AlphaVac Thrombectomy System

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FDA clears an AngioDynamics 510(k) for the AlphaVac Mechanical Thrombectomy System, an off-circuit, multi-purpose mechanical aspir...

Quelicin Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that Hospiras Quelicin Preservative Free (succinylcholine chloride) injection, 20mg/mL, 50...

Workshop on Spinal Device Clinical Reviews

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