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Congress Should Do More on Drug Shortages: Analysis

[ Price : $8.95]

Manhattan Institute senior fellow and former FDAer Randall Lutter says there are many things Congress should be doing to alleviate...

Improve Post-Market Evidence Generation: Report

[ Price : $8.95]

The Reagan-Udall Foundation recommends steps to be taken by FDA and other stakeholders to improve evidence generation in postmarke...

Covidien Recalls Stolen Video Laryngoscopes

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

Republicans Threaten Subpoena on FDA Research

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House Energy and Commerce Committee Republicans threaten FDA with a subpoena if it continues to delay submitting documents on what...

BridgeBio Filing NDA for Acoramidis

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BridgeBio Pharma says it will file by 12/31 an NDA for acoramidis after releasing Phase 3 data from its ATTRibute-CM study of acor...

Data Support Wegovy Positive CV Outcomes

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Novo Nordisk says data from its landmark Phase 3 SELECT cardiovascular outcomes trial assessing the effects of once-weekly Wegovy ...

FDA Clears InMed.AI NeuroShield Tool

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FDA clears an InMed.AI 510(k) for NeuroShield, which the company describes as an automated brain geometry-based quantifying analyt...

Exparel Gains Expanded Analgesic Use

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FDA approves a Pacira BioSciences supplemental NDA to expand Exparels (bupivacaine liposome injectable suspension) label to includ...

Breakthrough Status for Brixton Coolio

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

Neurocrine Bio Stops 2 Develoment Programs

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