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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.

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...

More Suicide Deaths Linked to FDA Antidepressant Warnings

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University researchers worldwide urge FDA to reevaluate its use of a Boxed Warning in labeling for youth antidepressants after stu...

FDA Questions Data in Stealth NDA for Barth Syndrome

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FDA reviewers appear unconvinced that a Stealth BioTherapeutics NDA for elamipretide, a mitochondria-targeted therapy for treating...

Covid/Flu Rapid Test Authorized for OTC Use

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FDA grants a de novo marketing authorization for over-the-counter Healgen Rapid Check Covid-19/Flu A&B Antigen Test.

Workshop Advances Brain/Computer Interface Assessment

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FDA releases the transcript from a two-day workshop held in conjunction with NIH on developing clinical outcome assessments to dem...