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FDA Grants Priority Review for Liso-Cel in Marginal Zone Lymphoma
06 Aug 2025 11:24 GMT
… ).1 The FDA has set a Prescription Drug User Fee … profile, coupled with recent FDA approvals for streamlined patient … and the removal of the Risk Evaluation and Mitigation Strategy (REMS) program, aims … U.S. Food and Drug Administration (FDA) in Fifth Cancer …
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Royalty Pharma Reports Second Quarter 2025 Results
06 Aug 2025 11:00 GMT
… , Ferring Pharmaceuticals announced U.S. Food and Drug Administration (FDA) approval … funding arrangement with Revolution Medicines. The funding arrangement includes … the company’s proposed Risk Evaluation and Mitigation Strategy. No additional clinical data …
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Questions Arise As CAR T-Cell Therapy and Bispecific Antibody Use Increase in Relapsed/Refractory Myeloma
06 Aug 2025 19:05 GMT
… The new REMS [Risk Evaluation and Mitigation Strategies] update is very promising … Drexel University College of Medicine in Philadelphia, Pennsylvania, … toxicities and also using drugs like tocilizumab [Actemra] … #47;NEJMoa2303379
US FDA approves Bristol Myers …
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Onco360® Has Been Selected as a Specialty Pharmacy Partner for LYNOZYFIC™ (linvoseltamab-gcpt)
04 Aug 2025 20:30 GMT
… the Food and Drug Administration to treat … syndrome (ICANS). The FDA accelerated approval for … program called the Lynozyfic Risk Evaluation and Mitigation Strategy (REMS). Please read … Corporation, a leading institutional pharmacy, specialty infusion, and …
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Life Science & Healthcare Private Equity Risk: Q2 2025 Update
06 Aug 2025 10:00 GMT
… Therapies: The FDA eliminated the Risk Evaluation and Mitigation Strategies (REMS) for … The Centers for Medicare & Medicaid Services (CMS) … existing drug approvals, potential legalization of drug … practices in the pharmaceutical industry. The sessions …
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Apellis Pharmaceuticals Reports Second Quarter 2025 Financial Results
31 Jul 2025 11:05 GMT
… the U.S. Food and Drug Administration (FDA) as the first treatment … a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the EMPAVELI … encapsulated bacteria, and Medication Guide. About Apellis
Apellis Pharmaceuticals, Inc. is a …
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Biotech Stocks Facing FDA Decision In August 2025
30 Jul 2025 15:53 GMT
… . (IONS)
Ionis Pharma';s Donidalorsen, an investigational RNA-targeted medicine, is at the FDA altar, with … -fetal toxicity monitoring Risk Evaluation and Mitigation Strategy (REMS) for the kidney drug Filspari is at the FDA altar, with a …
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USFDA lifts Risk Evaluation and Mitigation Strategies for CAR T cell therapies
28 Jun 2025 12:40 GMT
… and Drug Administration (USFDA) has announced that it has eliminated the Risk Evaluation and Mitigation Strategies … program that the FDA can require for certain medications with serious … benefits of the medication outweigh its risks.
The FDA determined that …
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FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor CAR T cell Immunotherapies
28 Jun 2025 01:35 GMT
… and Drug Administration announced today that it has eliminated the Risk Evaluation and Mitigation Strategies (REMS … program that the FDA can require for certain medications with serious … benefits of the medication outweigh its risks.
The FDA determined that …
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FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor CAR T cell Immunotherapies
27 Jun 2025 20:52 GMT
… and Drug Administration announced today that it has eliminated the Risk Evaluation and Mitigation Strategies (REMS … program that the FDA can require for certain medications with serious … benefits of the medication outweigh its risks.
The FDA determined that …