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Zealand Hypoglycemia NDA Denied FDA Approval

[ Price : $8.95]

FDA issues Zealand Pharma a complete response letter on its NDA for dasiglucagon and its use in preventing and treating hypoglycem...

Bayer Files NDA for Menopause Drug

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FDA accepts a Bayer NDA for elinzanetant, a non-hormonal investigational compound for treating moderate-to-severe hot flashes asso...

FDA Exempts Some from Supply Chain Security Act

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FDA grants exemptions to Drug Supply Chain Security Act eligible connected trading partners, pushing the implementation date for e...

GSK Says Arexvy Protects Over Three RSV Seasons

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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.

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...