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Workshop on Patient Experience Data in Drug Development

[ Price : $8.95]

FDA announces a two-day virtual public workshop to address methodological challenges in using patient experience data in drug deve...

Wegovoy OKd for Metabolic Steatohepatitis

[ Price : $8.95]

FDA grants Novo Nordisk accelerated approval for a new Wegovy (semaglutide) indication for treating metabolic dysfunction-associat...

FDA OKs Tonix Drug for Fibromyalgia

[ Price : $8.95]

Tonix Pharmaceuticals gains approval for Tonmya (cyclobenzaprine HCl sublingual tablets), a once-daily, non-opioid drug for treati...

FDA Delays Clinical Hold Review on Neurizon ALS Drug

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Staffing cuts and other administrative disorders leads to a review extension on a clinical hold review on Neurizon Therapeutics N...

FDA Alert on Baxter Novum Infusion Pumps

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FDA issues an alert on all Baxter Novum IQ Large Volume Pumps and Novum IQ Syringe Pumps after becoming aware of a company notific...

Omeros BLA for Narsoplimab Gets Review Extension

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FDA extends by three months its review of an Omeros resubmitted BLA for narsoplimab in hematopoietic stem cell transplant-associat...

FDA OKs Papzimeos for Respiratory Papillomatosis

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FDA approves a Precigen BLA for Papzimeos (zopapogene imadenovec-drba), a non-replicating adenoviral vector-based immunotherapy fo...

Alert on Medtronic DLP Left Heart Vent Catheters

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FDA issues an alert after becoming aware that Medtronic recently sent a letter to customers recommending that certain DLP Left Hea...

Sickle Cell Drug Misses Phase 3 Endpoint: Pfizer

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A Phase 3 study of Pfizers investigational sickle cell disease drug inclacumab fails to meet the primary endpoint.

BEAM-101 Gets Advanced Therapy Designation

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FDA grants Beam Therapeutics a Regenerative Medicine Advanced Therapy designation for BEAM-101, an investigational gene-edited cel...