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FDA Misses Review Decision on Stealth Bio NDA

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FDA misses a 4/29 user fee review action extension on a Stealth BioTherapeutics NDA for elamipretide, a first-in-class mitochondri...

Amazon Selling Unapproved, Misbranded Drugs: FDA

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FDA warns Amazon it is marketing unapproved and misbranded external analgesic drug products for use before sensitive cosmetic proc...

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...

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...

Medtronic Files PMA for Hugo Urology Surgical Robot

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Medtronic files a PMA for its Hugo robotic-assisted surgery system for a urologic indication.