By Angus Liu
The FDA is poking holes in Acadia's second try for expanding Nuplazid into a new neurological disorder—and in doing so, the agency has revealed a chasm in the data that the company likely won’t be able to remedy without an additional clinical trial.
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By Andrea Park
After kicking off the year by shipping out a record number of its Tablo hemodialysis systems for at-home users, Outset Medical has brought those sales to a screeching halt.
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By Paige Minemyer
The Supreme Court on Wednesday unanimously rejected massive payment cuts to hospitals under the 340B drug discount program. The controversial program still has other legal battles to face, though.
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By Nick Paul Taylor
Immunic has drummed up some enthusiasm for its multiple sclerosis candidate, highlighting the release of previously published data in a peer-reviewed journal and sharing an update on its next trial to claw back a sliver of the value it lost after its ulcerative colitis flop.
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By Ben Adams
CSL Behring teamed up with renowned portrait photographer Rankin to launch “Portraits of Progress,” a project that charts 60 years in the fight against hemophilia.
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By Angus Liu
Pfizer’s Paxlovid has proven useful in COVID-19 patients at high risk of severe disease. But the antiviral drug may not help less vulnerable patients, a clinical trial has shown.
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By Andrea Park
Boston Scientific is adding a familiar face to its family of medical devices.
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By Heather Landi
Mental health startup Cerebral's problems continue to mount as the Federal Trade Commission is now investigating the company's business practices, according to media reports.
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By Annalee Armstrong
MorphoSys has found a home for a couple of assets it doesn’t want anymore—a nice billion-dollar home, that is—as the German biotech shifts focus to oncology.
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By Fraiser Kansteiner
Just one day after Amylyx Pharmaceuticals’ new amyotrophic lateral sclerosis (ALS) med Albrioza passed muster with Canadian regulators, U.S. watchdog ICER has taken aim at the drug’s cost effectiveness in a new draft report.
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By Conor Hale
Shortly after garnering a European green light for its digital pathology platform, the software developer Proscia has posted a $37 million venture capital round, which will also help it seek additional product approvals.
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By Dave Muoio
A hypothetical single-payer system would have saved nearly 339,000 lives from COVID-19 and other diseases during the pandemic's first two years while saving hundreds of billions in spending, researchers estimated in a newly published study.
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