Approvals
Lenacapavir, to be marketed as Yeztugo, could “redefine the PReP market,” according to analysts.
Industry watchers responded mostly positively to the commissioner’s new voucher program, but worries remain over staffing cuts at the agency.
Andembry is the first monthly Factor XIIa inhibitor for the prevention of HAE attacks and will be available to patients “before the end of June,” CSL announced.
The program will bring together experts from across the FDA for a team-based review, rather than having an application move across numerous offices within the agency before getting a yay or nay.
According to an internal email, the agency may be in for more consolidation in areas including human resources, communications, travel and acquisitions.
The FDA’s Oncologic Drugs Advisory Committee narrowly voted against the approval of Zusduri, citing the lack of a completely randomized study to back up the application.
Merck’s Enflonsia will go up against Sanofi and AstraZeneca’s Beyfortus, which the partners plan to ship out early in the third quarter.
Jefferies analysts said the approval was largely expected and an “incremental positive” for Moderna amid questions about the FDA’s attitude toward mRNA and COVID-19 vaccines that have investors worried.
The approval tees GSK up to challenge Sanofi and Regeneron, which in September 2024 won the first biologic approval for COPD for their blockbuster antibody Dupixent.
The FDA also approved the use of Zynyz as a monotherapy for patients with squamous cell carcinoma of the anal canal who are intolerant to platinum chemotherapy or whose disease has progressed.
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