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Court Rules Against FDA in Vaccine FOIA Request

[ Price : $8.95]

A Texas federal court rules against FDA in a Freedom of Information Act lawsuit by a group seeking data and information on the Pfi...

Moderna Booster Shot Shortened to 5 Months

[ Price : $8.95]

FDA amends the emergency use authorization for the Moderna Covid-19 vaccine to shorten the time between the completion of primary ...

AbbVie sNDA for Rinvoq in Axial Spondyloarthritis

[ Price : $8.95]

AbbVie files a supplemental NDA for Rinvoq (upadacitinib,15 mg once daily) for treating certain adults with active non-radiographi...

PhRMA Study Finds 50% of Drug Pricing Goes to Middlemen, Others

[ Price : $8.95]

A PhRMA-funded study finds that more than half of every $1 spent on brand medicines went to payers, middlemen, providers, and othe...

BD Bacterial Identification Testing System Cleared

[ Price : $8.95]

FDA clears a Becton, Dickinson 510(k) for the BD Kiestra IdentifA system, which is designed to automate preparation of microbiolog...

CDER Supports PBPK Modeling for Generic Bioequivalence

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CDER embraces industrys use of physiologically based pharmacokinetic modeling as an alternative bioequivalence (BE) approach after...

Dont Conduct Proprietary Name Analysis: PhRMA

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PhRMA and Lilly say a proposed FDA study on proprietary names is not likely to provide useful information.

Biolase 510(k) for Root Canal Laser Cleared

[ Price : $8.95]

FDA cleares a Biolase 510(k) for the EdgePro system for cleaning and disinfection during root canal procedures performed by endodo...

FDA Approves Rexulti for Pediatric Patients

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FDA approves an Otsuka America Pharmaceutical and H. Lundbeck supplemental NDA for Rexulti (brexpiprazole) for treating schizophre...

Medtronic Recalls Neurosurgical Navigation Software

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Medtronic recalls its Synergy Cranial and StealthStation S7 Cranial software due to potential inaccuracies caused by the devices B...