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President Trump plans to remove FDA Commissioner Marty Makary amid disputes over vaping policy, the abortion pill, and drug rejections. A leadership change at the agency could shift approval timelines and regulatory priorities affecting pharma and biotech sectors.
A federal court has ordered that mifepristone, the most commonly used abortion pill in the U.S., can only be dispensed in person at clinics, overriding FDA rules that allowed mail delivery. The ruling is expected to be appealed to the Supreme Court, leaving access and compliance obligations uncertain in the interim.
The FDA is examining expanded testosterone therapy approvals for libido while GLP-1's grip on obesity treatment faces a scientific challenge from its own pioneers. Researchers now argue GIP-glucagon dual targeting may match GLP-1 efficacy with better tolerability. Kailera Therapeutics raised $625 million in what is
Medicare is considering ending its breakthrough device payment pathway, which currently fast-tracks reimbursement for FDA-designated novel medical devices. Removal would push manufacturers into standard, slower coverage reviews, undermining the commercial case for early-stage medtech innovation. No timeline for a final
Tag
President Trump plans to remove FDA Commissioner Marty Makary amid disputes over vaping policy, the abortion pill, and drug rejections. A leadership change at the agency could shift approval timelines and regulatory priorities affecting pharma and biotech sectors.
1mo ago · 2 min · Policy & Government
A federal court has ordered that mifepristone, the most commonly used abortion pill in the U.S., can only be dispensed in person at clinics, overriding FDA rules that allowed mail delivery. The ruling is expected to be appealed to the Supreme Court, leaving access and compliance obligations uncertain in the interim.
1mo ago · 2 min · Policy & Government
The FDA is examining expanded testosterone therapy approvals for libido while GLP-1's grip on obesity treatment faces a scientific challenge from its own pioneers. Researchers now argue GIP-glucagon dual targeting may match GLP-1 efficacy with better tolerability. Kailera Therapeutics raised $625 million in what is
2mo ago · 1 min · Business
Medicare is considering ending its breakthrough device payment pathway, which currently fast-tracks reimbursement for FDA-designated novel medical devices. Removal would push manufacturers into standard, slower coverage reviews, undermining the commercial case for early-stage medtech innovation. No timeline for a final
2mo ago · 1 min · Policy & Government
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