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Bladder Cancer Drug Meets Primary Endpoint: Pfizer

[ Price : $8.95]

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.

BlackfinBio Plans Gene Therapy Trial

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FDA clears BlackfinBio to conduct a Phase 1/2 clinical trial of its novel adeno-associated virus gene therapy, BFB-101, in childre...

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...

FDA Clinical Hold on VYNEs Psoriasis Drug

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FDA issues a clinical hold on VYNE Therapeutics Phase 1b study evaluating VYN202 for treating moderate-to-severe plaque psoriasis ...

RFK Jr. Restoring FDAs Freedom of Information Office

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HHS secretary Robert F. Kennedy Jr. vows to restore FDAs and other health agencies Freedom of Information Act (FOIA) offices that ...

Breakthrough Status for Blood Pressure Therapy

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FDA grants Orchestra BioMed a breakthrough device designation for its atrioventricular interval modulation therapy that uses a pac...

Texas Court Gives FDA Win in Compounding Enforcement

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A Northern Texas federal judge denies a preliminary injunction sought by Outsourcing Facilities Association to delay FDA enforceme...