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FDA Fast Tracks Arialys ART5803

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FDA grants Fast Track designation to Arialys Therapeutics ART5803 to treat anti-NMDA receptor encephalitis.

White House Looking at 3 Possible FDA Commissioners: Reports

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Referencing a Stat online report, MSN identifies three finalists to replace Marty Makary as FDA commissioner.

FDA Drug, Biologics Centers Continue Workforce Decline

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CDER and CBER continue to experience net workforce losses through the first nine months of fiscal year 2026, although hiring impro...

AstraZeneca, Ionis' Wainua Misses Phase 3 Study Endpoint

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AstraZeneca and Ionis Pharmaceuticals say that their Phase 3 CARDIO-TTRansform trial evaluating Wainua (eplontersen) in patients w...

Increase in Drug WLs Shows Structural Problem: Analysis

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Krieger Scientific CEO Joseph Morwald says a 59% increase in FDA drug Warning Letters in 2025 over 2024 should be seen by industry...

Hearing on FDA's Role in Retaining Biomedical Innovation in U.S.

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A Capitol Hill hearing next week examines how FDA can help strengthen the nation's leadership in biomedical innovation.

Petition Asks Committee Review of Anticholinergic Drugs

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Two former FDAers petition the agency to appoint an advisory committee to consider whether anticholinergic drugs are associated wi...

Restore Former Inspection Processes: Gortler

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Former FDAer David Gertler says its time for the agency to resume the unannounced, in-person inspections of drug and medical devic...

Catalent Indiana FDA-483 Out

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FDA releases the form FDA-483 with eight observations from a reinspection at the Bloomington, IN-based Catalent Indiana sterile dr...

Amphastar Subsidiary Gets Warning Letter for California Facility

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FDA sends Amphastar Pharmaceuticals subsidiary International Medication Systems a Warning Letter citing current GMP violations at ...