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.
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.
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.
As the digital asset market matures, two powerful forces—comprehensive U.S. regulation and a pivot toward tokenized stable assets—are poised to redefine the trading landscape by 2026, potentially attracting a new wave of capital while curbing volatility.
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.
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.
President Donald Trump's selection of former Fed Governor Kevin Warsh to lead the central bank is widely seen as a move to accelerate the rollback of post-crisis financial rules and align regulatory policy more closely with White House objectives, analysts say.
Chinese tutoring giant TAL Education Group surpassed revenue and profit expectations for its fiscal third quarter, reporting net income of $130.6 million. The results signal a successful strategic pivot following China's sweeping education sector reforms.
Kuwait mandates sweeping regulations on food delivery platforms, capping commissions and banning exclusivity deals after uncovering anti-competitive practices that hurt restaurants and consumers.
As a federal judge advances a lawsuit tying Bank of America to Jeffrey Epstein's sex trafficking network, the financial giant simultaneously positions itself at the forefront of stablecoin regulation discussions with Coinbase and the White House, creating a complex risk-and-opportunity landscape for investors.
A reported fiery exchange between JPMorgan's Jamie Dimon and Coinbase's Brian Armstrong at the World Economic Forum lays bare the intensifying battle between traditional finance and the crypto industry over regulation, deposits, and the future of money.
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.
New research reveals a stark preparedness gap among UK manufacturers and wholesalers for the impending EU Digital Product Passport (DPP), with nearly half unaware of the regulation that could bar non-compliant goods from the single market.
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.
