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GSK Says Arexvy Protects Over Three RSV Seasons

[ Price : $8.95]

GSK says trial data show its Arexvy protects through three complete RSV seasons.

6 Baxter Products in Shortage Due to Hurricane: FDA

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FDA says six products manufactured at Baxters hurricane-damaged facility in North Carolina are now on the shortage list.

Do More to Prevent DSCSA Disruptions: Congress

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Some 21 House Democrats and Republicans ask FDA to take more steps to prevent drug shortages as the Drug Supply Chain Security Act...

Neuvivo Files NDA for Lou Gehrigs Therapy

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Neuvivo files an NDA for NP001 (sodium chlorite infusion) for treating amyotrophic lateral sclerosis (also known as Lou Gehrigs di...

FDA New Alternative Methods Office Needed: Report

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An FDA Science Advisory Board subcommittee calls on the agency to create a centralized office to coordinate work on New Alternativ...

Objectionable Conditions at LSU Institutional Review Board

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FDA warns the Louisiana State University institutional review board that it failed to follow legislation and regulations to protec...

FDA Releases Apitoria Pharma FDA-483

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FDA releases the form FDA-483 with 10 observations from an inspection at the Apitoria Pharma active pharmaceutical ingredient manu...

8 Observations in Biocon FDA-483

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FDA releases the form FDA-483 issued following an inspection at the Biocon sterile drug product manufacturing facility in Johor, M...

House Wants FDA Briefing on Fake Ozempic

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The House Energy and Commerce Committee asks FDA for a staff briefing about the presence of counterfeit copies of Novo Nordisks Oz...

Sentec/Percussionaire Recalls Ventilator Valve

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Sentec/Percussionaire recalls (Class 1 device correction) its Phasitron 5 In-Line Valve to update use instructions due to an incre...