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Zealand Hypoglycemia NDA Denied FDA Approval

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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...

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...

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...