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Sen. Josh Hawley pressures FDA chief to limit access to abortion pill
12 Dec 2025 22:42 GMT
… of two drugs used for medication abortion and … mifepristone separate from the (Risk Evaluation and Mitigation Strategies) process,” if Makary … includes the FDA, said that “FDA’s comprehensive … one of two pharmaceuticals used in medication abortion. It …
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Hawley seeks explanation from FDA over delayed mifepristone safety review
12 Dec 2025 03:28 GMT
… explanation from Food and Drug Administration (FDA) Commissioner Marty Makary … ongoing FDA monitoring through standard procedures known as REMS (Risk Evaluation and Mitigation Strategy), … standard monitoring FDA already performs for countless drugs."
…
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Hawley Ramps Up Pressure on FDA Chief After Daily Signal Interview
11 Dec 2025 01:18 GMT
… demanding answers from Food and Drug Administration Commissioner Dr. Marty … the standard monitoring FDA already performs for countless drugs.”
The science … if the FDA has plans to update the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) “ …
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Hawley demands answers from FDA after reports they delayed review of abortion drug
10 Dec 2025 23:14 GMT
… letter to Food and Drug Administration (FDA) Commissioner Marty Makary following … the standard monitoring FDA already performs for countless drugs.
There are … Does the FDA have any plans to update the Mifepristone Risk Evaluation and Mitigation Strategy (REMS …
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Missouri Sen. Hawley amps up pressure campaign on FDA chief to limit medication abortion
10 Dec 2025 20:37 GMT
… of the chemical abortion drug and its generics, … mifepristone separate from the (Risk Evaluation and Mitigation Strategies) process,” if Makary … includes the FDA, said that “FDA’s comprehensive … one of two pharmaceuticals used in medication abortion. It …
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STAT+: Pharmalittle: We’re reading about FDA plans for CAR-T therapies, skinny drug labels, and much more
10 Dec 2025 16:40 GMT
… to market medicines.
The U.S. Food and Drug Administration is … will accept for regulatory filings, Pharmaphorum writes. At the moment, … the FDA loosened requirements for safety monitoring by eliminating the risk evaluation and mitigation strategies …
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<![CDATA[FDA Outlines New Superiority Standard for Future CAR-T Approvals]]>
10 Dec 2025 01:44 GMT
… FDA perspective will impact the potential therapy.
Meanwhile, pharmas … extensive experience of the medical hematology/oncology community … availability-biologics/fda-eliminates-risk-evaluation-and-mitigation-strategies-rems-autologous-chimeric-antigen …
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FDA set to raise bar for clinical trials of CAR-T therapies
09 Dec 2025 14:50 GMT
… the Journal of the American Medical Association (JAMA).
The move … FDA loosened the requirements for safety monitoring by eliminating the risk evaluation and mitigation strategies … as the FDA is steadily rewriting the regulations surrounding drug development …
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<![CDATA[FDA Approves Liso-Cel as First CAR T-Cell Therapy for Marginal Zone Lymphoma]]>
05 Dec 2025 13:35 GMT
… coupled with recent FDA approvals for streamlined … the removal of the Risk Evaluation and Mitigation Strategy (REMS) program, aims … transplant.
REFERENCES
1. FDA approves lisocabtagene maraleucel for … S. Food and Drug Administration (FDA) in fifth cancer …
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The New England Journal of Medicine Publishes Positive Phase 3 VALIANT Results of EMPAVELI® (pegcetacoplan) for C3G and Primary IC-MPGN
03 Dec 2025 22:05 GMT
… professor of internal medicine and pediatrics and director … restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the … patient with antibacterial drug prophylaxis and administer … . About Apellis
Apellis Pharmaceuticals, Inc. is a …