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Revoke All mRNA Covid Vaccine BLAs: CHD Petition

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Childrens Health Defense asks FDA to revoke BLA approvals for all Pfizer and Moderna mRNA Covid-19 vaccines, claiming they do not ...

HCT/P Violations at Ponya Therapeutics

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FDA warns Brookhaven, GA-based Ponya Therapeutics about violations of regulations governing human cells, tissues, and cellular and...

FDA Clears Rx Digital Therapeutic for Adult ADHD

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FDA clears a Lumos Labs 510(k) for LumosityRx, a prescription digital therapeutic intended to improve attention in adults with att...

Positive Results for Roche Giredestrant in Some Breast Cancers

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Roche reports positive Phase 3 lidERA trial results for its giredestrant selective estrogen receptor degrader endocrine therapy in...

FDA Neurological Regulator Joins Musks Neuralink

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Reuters reports that Daniel McMullen, the former director of the CDRH Office of Neurological and Physical Medicine Devices, has jo...

FDA Raises Approval Standards for CAR-T Cancer Therapies

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CBER officials pen a new JAMA article signaling a major policy shift for cancer CAR T-cell therapies, moving away from reliance on...

Potential Redefinition of Enforcement Boundaries: Attorneys

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Four Hogan Lovells attorneys describe a potential significant shift in Justice Department enforcement boundaries, especially invol...

CGMP Issues at Seaway Pharma

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FDA warns Massena, NY-based Seaway Pharma about long-standing CGMP violations in its production of finished drugs as a contract ma...

First Approval Under New Priority Voucher Program

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FDA approves Augmentin XR (amoxicillinclavulanate potassium) through the new Commissioners National Priority Voucher pilot program...

Prescription to Nonprescription Switch MAPP

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CDER issues a Manual of Policies and Procedures for when a reference-listed drug switches from prescription to nonprescription mar...