FDA Regulation

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Nevada Court Blocks Polymarket, Citing Precedent in Crypto Prediction Market Crackdown

A Nevada judge has barred prediction market platform Polymarket from operating in the state, leaning on recent federal rulings against similar platforms. The decision marks a significant setback for the company's regulated U.S. relaunch and underscores the ongoing legal tension between state gambling laws and federal commodities regulations.

Business

Gilead Sciences Oncology Update After Positive Trodelvy Keytruda Trial Results

Gilead Sciences (NasdaqGS:GILD) reported positive Phase 3 ASCENT-04/KEYNOTE-D19 results for Trodelvy plus Keytruda in first-line metastatic triple-negative breast cancer. Full Phase 3 clinical data were published in a leading medical journal, highlighting efficacy and safety outcomes for the combination regimen. Following these results, Gilead submitted supplemental regulatory filings to the FDA and EMA seeking expanded use of Trodelvy in this setting. For you as an investor, this update...

Business

Oscar Health Faces Headwinds as CMS Proposes Tighter Medicare Advantage Rules

The Centers for Medicare & Medicaid Services (CMS) has unveiled a proposed payment update for Medicare Advantage plans that falls below industry expectations, coupled with stricter risk-adjustment regulations. This dual challenge pressures insurers like Oscar Health (NYSE: OSCR), whose tech-driven model is now under the microscope as profitability margins face a squeeze.