FDA

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MedTech

Nyxoah plans US debut of OSA implant, as rival lobs patent suit

Nyxoah’s neuromodulation therapy for obstructive sleep apnea has claimed FDA approval—but its U.S. rollout may hit a legal roadblock.

Conor Hale Aug 13, 2025 11:00am

increase

SetPoint nets $140M following FDA neuromod approval in RA

Aug 11, 2025 11:30am

FDA

Fierce Pharma

Vinay Prasad is back at the FDA after last month's surprise ouster

Aug 9, 2025 12:22pm

question ask wonder who why

FDA denies request to reconsider Stealth's ultrarare disease med

Aug 8, 2025 1:58pm

FDA

FDA formally kicks off medical device user fee negotiations

Aug 4, 2025 4:45pm

Monoclonal antibody orange red background 3d rendering

Allogene reports patient death tied to mAb in CAR-T pivotal trial

Aug 1, 2025 8:30am