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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...

Two Stakeholder Comments on BCG-Unresponsive Guide

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Two stakeholders recommend changes to an FDA draft guidance on treatment development for Bacillus Calmette-Guerin-Unresponsive Non...

Significant CGMP Violations at MMC Healthcare

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FDA warns Indias MMC Healthcare about CGMP violations in its production of finished drugs.

Hospital Group Seeks FDA Actions in IV Solution Shortages

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The American Hospital Association asks the Biden Administration to require FDA to take immediate actions to increase the supply of...

Woodcock Joins Board at Drug Repurposing Nonprofit

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Former FDA principal deputy commissioner Janet Woodcock joins the board of directors at Every Cure, a nonprofit organization that ...

Respironics Recalls Trilogy Ventilators Over Nebulizers

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Philips Respironics recalls (Class 1 device correction) its Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, and Trilogy EV300 ...

Clinical Hold Slapped on Kezar Lupus Trial

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FDA orders a clinical hold on Kezar Life Sciences IND for zetomipzomib and its investigational use in treating lupus nephritis.