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FDA Roundup: May 31, 2024

FDA Roundup: May 31, 2024
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United States , Eli Lilly , Health Data In Medical Device Development , Autonomous Medical Systems Saams Collaborative Community , Office Of Media Affairs , Drug Administration , Moderna Modernatx Inc , Pilot Program , Openoximetry Collaborative Community , Juno Therapeutics Inc , Digital Medicine Society , Computer Interface Collaborative Community , Centers For Medicare Medicaid Services , Centers For Disease , Respiratory Syncytial Virus Vaccine , Safeguarding Therapeutics Act , Drug Omnibus Reform Act , Consolidated Appropriations Act , Federal Food , Autonomous Medical Systems , Juno Therapeutics , Risk Evaluation , Mitigation Strategy , Clinical Trials Advancing Rare , Biologics Evaluation , Drug Evaluation ,

FDA's new platform guidance aims to smooth regulatory encounters

FDA's new platform guidance aims to smooth regulatory encounters
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United States , Peter Marks , American Society Of Gene Cell Therapy , Drug Evaluation , Biologics Evaluation , American Society , Cell Therapy ,

FDA urged to relax decades-old tissue donation restrictions for gay and bisexual men

FDA urged to relax decades-old tissue donation restrictions for gay and bisexual men
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Des Moines , United States , Betts Jr , Joe Neguse , Sridhar Basavaraju , Kevin Corcoran , Peter Marks , Michael Puente Jr , Rae Ellen Bichell , Scott Haber , Sherylj Moore , Jackson Moore , American Academy Of Ophthalmology , University Of Colorado School Medicine , Eye Bank Association Of America , Iowa Donor Network , Centers For Disease , Office Of Blood , Us Public Health Service , Health News , Michael Puente , Colorado School , Hospital Colorado , Biologics Evaluation , Health Service , Disease Control ,

VBI Vaccines Announces New Tumor Response Data from Ongoing Randomized Controlled Phase 2b Study of VBI-1901 in Recurrent Glioblastoma Patients

Among the 7 patients on VBI-1901 treatment long enough to have 1+ MRI scan at the time of analysis, one partial tumor response and two stable disease observations have occurred as of May 15,. ....

United Kingdom , United States , Prehevbrio Prehevbri , Brii Biosciences , Davide Anderson , Jeff Baxter , Company Quarterly Reports On Form , American Society Of Clinical Oncology , Vaccines Inc , Oncology Center , Drug Administration , Clinical Oncology , Annual Meeting , Scientific Officer , Fast Track , Orphan Drug Designations , Data Poster Highlights , Study Arm , Granulocyte Macrophage Colony Stimulating Factor , Randomized Phase , Central Nervous System Tumors , Patient Enrollment , Study Design , Study Data Highlights , Track Designation , Orphan Drug Designation ,

FDA urged to relax decades-old tissue donation restrictions for gay and bisexual men

The federal government in 2020 and 2023 changed who it said could safely donate organs and blood, reducing the restrictions on men who have had sex with another man. ....

United States , Kevin Corcoran , Peter Marks , Betts Jr , Joe Neguse , Sridhar Basavaraju , Michael Puente Jr , Sherylj Moore , Scott Haber , University Of Colorado School Medicine , American Academy Of Ophthalmology , Office Of Blood , Us Public Health Service , Centers For Disease , Eye Bank Association Of America , Iowa Donor Network , Health News , Tribune Content Agency , Michael Puente , Colorado School , Hospital Colorado , Biologics Evaluation , Health Service , Disease Control , American Academy , Eye Bank Association ,