fda-and-biotech News
Axogen Shares Climb on Landmark FDA Approval for Nerve Repair Graft
The U.S. regulator's decision validates AVANCE® Nerve Graft as a biologic, a pivotal milestone expected to accelerate market adoption and solidify the company's leadership in nerve repair.
Vaccine Stocks Tumble on New FDA Policy Concerns
Moderna, BioNTech, and Novavax shares fall after former FDA chiefs warn that proposed regulatory shifts could create significant hurdles for future vaccine approvals.
Apellis Shares Rise on NEJM Validation of Kidney Drug Empaveli
Prestigious medical journal publishes positive Phase 3 data, reinforcing the drug's efficacy for two rare kidney diseases and bolstering its commercial prospects.
Bristol Myers Jumps 4% on Alzheimer's Drug Trial Progress
An independent committee recommended the continuation of a late-stage study for a drug treating psychosis in Alzheimer's patients, boosting a key pipeline asset.
Cardio Diagnostics Secures Key Medicare Rate for AI Heart Tests
CMS finalizes an $854 payment rate for the company's novel cardiovascular diagnostics, a critical step toward commercialization and wider market access.
ADC Therapeutics Dips Despite Stellar Cancer Trial Results
Shares fall in a 'sell the news' reaction as investors grapple with positive new data seemingly overshadowed by outdated reports from a discontinued study.
Capricor Shares Jump on Positive Phase 3 Muscular Dystrophy Drug Data
Pivotal HOPE-3 trial for cell therapy deramiocel meets primary and key cardiac endpoints, paving the way for a renewed FDA submission.
Black Diamond Stock Surges on Promising Lung Cancer Drug Data
Silevertinib shows high response rates, especially in brain metastases, prompting the company to launch a new trial for the aggressive brain cancer glioblastoma.