American Hospital Association CEO to retire
Rick Pollack, who has served as leader of the hospital lobby since 2015, will retire by the end of next year. The AHA will conduct a nationwide search for his replacement.
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FDA pilots allowing digital health devices access to CMS payment program
Companies can ask the FDA to waive premarket authorization and investigational device requirements while they collect real-world data in a CMS program.
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First Commissioner’s Priority Review Approval Goes to Decades-Old Antibiotic
The Commissioner’s National Priority Voucher program was launched in June to shorten review times for companies that align with various national priorities, such as improving domestic drug production and supply.
First Commissioner’s Priority Review Approval Goes to Decades-Old Antibiotic Read More »
Natera acquires Foresight Diagnostics for up to $450M
Foresight’s technology will be integrated into Natera’s Signatera platform and is expected to be launched for clinical use in 2026.
Natera acquires Foresight Diagnostics for up to $450M Read More »
Teleflex inks deals to sell 3 businesses for $2B
Needham analysts said Teleflex’s inability to secure a price above the low end of their expectations could reflect “the continued poor performance of UroLift.”
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Early ACA enrollment holds steady despite subsidy turmoil
Some 5.8 million people have signed up for 2026 ACA plans so far, up about 7% year over year. Still, enrollment tends to shift over signup periods, so it’s too early to conclude that the Obamacare exchanges won’t shrink next year.
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CVS to launch ‘engagement’ platform in gamble on consumer, industry interest
CVS is bringing together its disparate businesses onto one platform, and giving its rivals the option to add their products and services as well. The goal is to improve consumers’ health engagement while generating more revenue.
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Crapo, Cassidy propose enhanced ACA subsidy alternative
The legislation, which is scheduled for a vote Thursday, would send funds directly to health savings accounts paired with bronze or catastrophic plans offered on the Affordable Care Act exchanges.
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First Commissioner’s Priority Review Approval Goes to GSK’s Decades-Old Antibiotic
The Commissioner’s National Priority Voucher program was launched in June to shorten review times for companies that align with various national priorities, such as improving domestic drug production and supply.
First Commissioner’s Priority Review Approval Goes to GSK’s Decades-Old Antibiotic Read More »
FDA Launches Probe Into Safety of Approved Anti-RSV Antibodies
The FDA has informed Merck, Sanofi and AstraZeneca of the safety investigation into their RSV antibodies, though it remains unclear what regulatory action, if any, will be taken.
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