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Roche, Eli Lilly Alzheimer’s Blood Test Gets FDA Clearance

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Roche and Eli Lilly’s Elecsys pTau217 blood test received U.S. FDA clearance on August 24, 2026. The test is intended for people aged 55 and older who have signs, symptoms, or complaints of cognitive decline. It measures phosphorylated tau 217, a biomarker associated with Alzheimer’s-related amyloid pathology. Results categorize patients as likely positive, likely negative, or intermediate for amyloid pathology, helping clinicians decide whether further evaluation may be needed. The test is not a standalone diagnosis. Doctors are expected to interpret it alongside symptoms, medical history, and other clinical information. It can run on more than 4,500 Roche laboratory analyzers already installed in the United States. Quest Diagnostics and Labcorp said they plan to offer it through their networks. The clearance follows European approval in May. Roche did not disclose pricing. The news does not represent the first FDA-authorized Alzheimer’s blood test: Fujirebio’s Lumipulse...

FDA Grants Orphan Drug Designation to Gamgertamig for Pemphigus

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GSK wins first hepatitis-B approval in Japan

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Roche Bets Up to $2.3 Billion on Hanmi’s Muscle-Preserving Obesity Drug

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RFK Jr. asks for public input on reshaping U.S. childhood vaccine recommendations

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FDA hold derails REGENXBIO’s planned RGX-121 refiling

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FDA Extends Capricor’s Deramiocel Decision Date to November 22

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Enhertu gains a potential first-line foothold in HER2-mutant NSCLC, but oral TKIs remain credible competitors

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Vivek Ramaswamy-backed Ambros Therapeutics to go public through Werewolf reverse merger

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EU Approves DAYBU as First Treatment for Rett Syndrome Neurobehavioral Symptoms

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Novo Nordisk Tests Lower Maintenance Doses of Oral Wegovy

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Genentech expands Oregon manufacturing while Bavarian Nordic delays Lyme vaccine trial

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Lilly teams with Amplitude on RNA vaccines

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