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Breakthrough Status for Brixton Coolio

[ Price : $8.95]

FDA gives Brixton Biosciences a breakthrough device designation for its Coolio Therapy, which is intended to deliver long-lasting ...

Covidien Recalls Stolen Video Laryngoscopes

[ Price : $8.95]

Covidien recalls its McGrath MAC Video Laryngoscope in a move to remove stolen defective models that have been offered for sale il...

Neurocrine Bio Stops 2 Develoment Programs

[ Price : $8.95]

Based on recent disappointing study data, Neurocrine Biosciences says it is stopping the development of two drugs being evaluated ...

Panel to Mull Multi-Cancer Detection Tests

[ Price : $8.95]

Federal Register notice: FDA announces an 11/29 advisory committee meeting to discuss multi-cancer detection IVDs.

Consent Decree Against Drug Distributor

[ Price : $8.95]

The Puerto Rico federal court enters a consent decree requiring Droguera Betances, one of the territorys largest pharmaceutical di...

Covid Broke Vaccine Reporting System: BMJ

[ Price : $8.95]

A BMJ investigation raises concerns that the federal governments vaccine adverse event system is not operating as planned and safe...

FDA OKs Chikungunya Vaccine

[ Price : $8.95]

FDA approves a Valneva Austria BLA for Ixchiq, a vaccine for preventing chikungunya in individuals aged 18 years and above who are...

BMS Files sBLA for Breyanzi Expanded Use

[ Price : $8.95]

FDA accepts for priority review a Bristol Myers Squibb supplemental BLA for Breyanzi (lisocabtagene maraleucel) to expand its curr...

FDA De Novo for Owlet Dream Sock

[ Price : $8.95]

FDA grants Owlet a de novo marketing authorization for its Dream Sock, an over-the-counter medical pulse oximetry solution for inf...

Samsung Seeks Interchangeable Humira Biosimilar

[ Price : $8.95]

FDA accepts for review a Samsung Bioepis supplemental BLA that seeks an interchangeability designation for its Hadlima (adalimumab...