Regulatory
The FDA will convene its Peripheral and Central Nervous System Drugs Advisory Committee to discuss Eli Lilly’s application for its Alzheimer’s disease antibody donanemab, the company announced Friday.
Judge Zahid Quraishi on Thursday appeared unconvinced by the pharmaceutical companies’ arguments that the Inflation Reduction Act’s Drug Price Negotiation Program violated the U.S. Constitution.
The FDA’s busy week ahead involves three decision dates for potential industry firsts and a highly anticipated advisory committee meeting for two CAR-T therapies.
The recently launched company shared two posters at the Muscular Dystrophy Association’s annual conference this week ahead of a March 21 PDUFA date.
Separate challenges exist for companies developing gene therapies for rare and common cardiovascular conditions, experts told BioSpace.
Despite its overall survival and disease progression benefits, the U.K.’s drug cost watchdog has declined to recommend AstraZeneca and Daiichi Sankyo’s Enhertu due to a lack of cost-effectiveness.
The FDA and CDC warned Thursday of a small increased risk of developing Guillain-Barré syndrome in older adults after immunization with respiratory syncytial virus vaccines from GSK and Pfizer.
Despite the approval of two novel therapies for this uniformly fatal neurodegenerative disease, experts say regulatory standards and expectations are still evolving.
The FDA will kick off March with three target action dates, including one for an insomnia treatment and another for a multiple sclerosis therapy.
On Wednesday, the CDC’s Advisory Committee on Immunization Practices voted to recommend Valneva’s chikungunya virus vaccine Ixchiq for certain high-risk patient groups.
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