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FDA OKs Expanded Clinolipid Use

[ Price : $8.95]

FDA approves Baxters expanded indication for parenteral (intravenous) nutritient Clinolipid (lipid injectable emulsion) for use in...

Respironics Recall of Trilogy Evo Ventilators

[ Price : $8.95]

Philips Respironics recalls (Class 1) its Trilogy Evo continuous ventilator devices due to a software issue that may cause a power...

Novo Nordisk Filing BLA for Hemophilia A Drug

[ Price : $8.95]

Novo Nordisk says it will seek FDA approval by the end of the year for Mim8, its next-generation Factor 8a mimetic bispecific anti...

Merus Breakthrough Status for Petosemtamab

[ Price : $8.95]

FDA grants Merus a breakthrough therapy designation for petosemtamab for treating certain patients with recurrent or metastatic he...

Warning on Cue Healths Covid Tests

[ Price : $8.95]

FDA issues a warning for healthcare providers and consumers not to use Cue Healths Covid-19 tests due to the increased risk of fal...

Eugia Sent 7-Item 483 After India Inspection

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FDA issues Eugia Pharma Specialties (an Aurobindo subsidiary) a seven-item Form-483 following a 5/3-concluded inspection at its st...

FDA Priority Review for Dupixent sBLA

[ Price : $8.95]

FDA accepts for priority review a Regeneron Pharmaceuticals and Sanofi supplemental BLA for Dupixent (dupilumab) as an add-on main...

Jemperlis Regulatory Review Period Determined

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for GlaxoSmithKlines Jemperli (...

Moderna RSV Vaccine Review Pushed Back

[ Price : $8.95]

FDA tells Moderna that it needs a couple more weeks to complete the review of its BLA for mRNA-1345, the companys investigational ...

Megadyne Removing Mega Soft Electrodes

[ Price : $8.95]

Megadyne recalls and removes from the market all Mega Soft Pediatric Patient Return Electrodes after receiving reports of patient ...