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CGMP Issues at BEO Pharmaceuticals

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FDA warns Brooksville, FL-based BEO Pharmaceuticals about CGMP violations in its manufacturing of finished drugs.

Abeona Gains Approval of Resubmitted Zevaskyn

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FDA approves Abeona Therapeutics Zevaskyn (prademagene zamikeracel) gene-modified cellular sheets, an autologous cell-based gene t...

Learn from Exer Labs Warning on AI Use: Attorneys

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Two Hogan Lovells attorneys discuss lessons medical device companies can learn about AI use from a recent FDA Warning Letter to Ex...

Trial Shows Value of Immunotherapy in Some Cancers

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A Memorial Sloan Kettering Cancer Center Phase 2 trial demonstrates the value of immunotherapy in MMRd genetic mutation cancers in...

No Broad FDA Reorganization Coming: Makary

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In a wide-ranging Inside Medicine Substack interview, FDA commissioner Martin Makary says there will be no broad reorganization at...

Senator Hawley Urges FDA Action on Mifepristone Study

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Senator Josh Hawley (R-Mo.) urges FDA commissioner Marty Makary to review a new study allegedly revealing greater safety risks tha...

FDA Turns Down Telix Glioma Imaging Agent

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FDA issues Telix Pharmaceuticals a complete response letter on its NDA for Pixclara (floretyrosine F18), a positron emission tomog...

Bladder Cancer Drug Meets Primary Endpoint: Pfizer

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Pfizer says the pivotal Phase 3 CREST trial of sasanlimab in combination with standard of care met its primary endpoint as an indu...

J&J Touts Bladder Cancer Data in Recent NDA

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J&J reports data from the Phase 2b SunRISe-1 study evaluating TAR-200, an intravesical gemcitabine releasing system, for patients ...

Novavax, HHS Clarify on Post-approval Covid Study

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Novavax and HHS clarify that FDA is requesting a post-approval study and not a clinical trial that must be conducted prior to appr...