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MPR1d
FDA Clears AI-Powered Wristband Device for Patients With Essential Tremor
The wearable, transcutaneous neurostimulation device delivers personalized therapy using a proprietary AI algorithm.
Gilead Sciences (GILD) Announces that US FDA Approves Yeztugo®as pre-exposure prophylaxis (PrEP)
Gilead Sciences, Inc. (NASDAQ:GILD) is one of the 10 Best Value Stocks to Buy According to Billionaires. The company ...
FDA vaccine official restricted COVID vaccine approvals against agency advice
A top official at the Food and Drug Administration recently overruled government scientists on the availability of two ...
MassDevice2d
Moon Surgical wins two FDA clearances for Maestro surgical robot
Moon Surgical today announced it received FDA 510(k) clearance for two new features on the Maestro robotic surgical assistant ...
Fierce Biotech2d
Kardium raises $250M as its pulsed field ablation system undergoes FDA review
The pulsed field ablation developer Kardium has collected $250 million in funding to gear up for the commercial expansion of ...
MassDevice2d
Fasikl wins FDA nod for tremor-treating wearable wristband
Fasikl announced that it received FDA 510(k) clearance for its first-of-its-kind NeuroAI wristband for essential tremor.
Fierce Pharma2d
Regulatory tracker: Merck nabs FDA priority review in bid to soup up Winrevair’s label
Welcome to Fierce Pharma's regulatory tracker for the second half of 2025. | In this tracker, Fierce Pharma is recording the ...
STAT4d
Many medical devices deemed ‘breakthrough’ by FDA are backed by patchy evidence
The FDA's breakthrough devices program helps the industry with faster review times, but the benefit to patients is unclear.
MarketWatch4d
Takeda Pharmaceuticals Gets FDA Approval for Liquid Gammagard
Takeda Pharmaceuticals said the Food and Drug Administration approved its liquid Gammagard immunoglobulin treatment. The drugmaker said Monday that commercialization of Gammagard Liquid is expected to ...