The FDA clearance of Spectrum Dynamics' Veritas.AI platform marks a significant step forward for nuclear imaging, promising to cut scan times in half and enhance image clarity for critical applications like cancer theranostics.
The FDA has cleared Intuitive Surgical's latest robotic system for use in certain heart surgeries, marking a strategic expansion into one of healthcare's largest and most complex service lines and potentially reshaping hospital capital planning for robotics.
Cogent Biosciences secures FDA Breakthrough Therapy Designation and enters the Real-Time Oncology Review program for its lead drug candidate bezuclastinib in gastrointestinal stromal tumors (GIST), marking significant regulatory momentum for the biotech firm.
Cogent Biosciences secures a key FDA Breakthrough Therapy Designation for its bezuclastinib-sunitinib combination in advanced GIST, following promising Phase 3 data that showed a halving of disease progression risk.
Glaukos Corporation secures a significant FDA nod allowing repeated administration of its sustained-release iDose TR implant, broadening treatment options for patients with glaucoma and potentially reshaping long-term care paradigms.
Glaukos Corporation's iDose TR glaucoma therapy receives a key FDA labeling update, permitting repeat administration. While the news bolsters the company's growth narrative, analysts are divided on whether its current stock price already reflects future potential amid rich valuation metrics.
The FDA's approval of a repeat treatment protocol for Glaukos's iDose TR implant transforms it from a one-time procedure into a potential chronic therapy platform, reshaping its commercial narrative and investor calculus in the competitive glaucoma market.
The FDA's Priority Review for Vyvgart's label expansion in myasthenia gravis accelerates Argenx's growth strategy, while investors weigh the company's broader pipeline against its current valuation.
Shares of Corcept Therapeutics plunged 16% after a corrected FDA letter disclosed the agency had repeatedly cautioned the company against filing its application for a Cushing's syndrome drug, which was later rejected over efficacy and safety concerns.
The U.S. Food and Drug Administration has issued a complete response letter for Aquestive Therapeutics' oral film drug designed to treat severe allergic reactions, the company announced Monday, delaying a potential new option for millions at risk.
Exelixis has filed its next-generation therapy zanzalintinib with U.S. regulators for metastatic colorectal cancer, marking a significant step in its clinical development and potentially enhancing its competitive position in the targeted oncology space.
The FDA has cleared Intuitive Surgical's da Vinci 5 robotic system for select complex cardiac procedures, a move that could reshape the landscape of minimally invasive heart surgery and open a significant new market for the industry leader.
Aeris Resources (ASX:AIS) shares have soared following a robust December quarter report featuring record copper-equivalent output and full repayment of a A$50 million debt facility. The operational momentum has fueled a dramatic 350% one-year shareholder return, yet analysts are divided on whether the stock's current price accurately reflects its underlying value or has overshot fundamentals.
Fractyl Health's Revita procedure shows promise in maintaining weight after stopping GLP-1 drugs, with new six-month data prompting the company to seek a streamlined FDA pathway. A packed 2026 roadmap aims for a U.S. submission, but financial pressures loom.
Vera Therapeutics (VERA) is drawing bullish attention from Wall Street, with multiple analysts significantly raising price targets following a key competitor's FDA approval and revised revenue forecasts for its lead drug candidate.
Following Federal Reserve clearance and robust Q4 results, Old Second Bancorp's board authorizes a significant share repurchase program. The move amplifies discussions on whether the regional bank's stock, despite steady gains, remains undervalued or if risks in its concentrated Illinois market are being overlooked.
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...
While fully autonomous robotic surgeons remain on the horizon, the foundational technology and data ecosystems being built today are setting the stage for a transformative shift. Two industry giants, Intuitive Surgical and Medtronic, offer investors distinct pathways to capitalize on this evolving landscape.
Edwards Lifesciences (NYSE: EW) has terminated its planned takeover of JenaValve, opting instead to reinvest capital into its internal transcatheter aortic (TAVR) and mitral valve development programs. The strategic pivot underscores a renewed focus on organic growth in its core structural heart business.
The European Commission has granted regulatory approval, concluding the acquisition of iconic Italian motorsports brand Dainese by asset management firms Arcmont and HPS Investment Partners, effectively placing ownership under major institutional investors.
