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Trump 2.0
At a CDC vaccine advisory committee criticized for “promoting an anti-vaccine agenda,” the new CDER director championed the committee’s plans and suggested the FDA would make more frequent vaccine label updates due to revised safety frameworks.
In another surprise leadership move, Commissioner Martin Makary named Høeg, who has stirred controversy with her involvement in FDA vaccine issues, the interim replacement for Richard Pazdur.
The soon-to-be former CDER director will return to the oncology office to complete his FDA tenure, the agency said.
In another surprise leadership move, Commissioner Martin Makary named Høeg, who has stirred controversy with her involvement in FDA vaccine issues, the interim replacement for Richard Pazdur.
FDA says Teresa Michele, in CDER nonprescription drugs program leadership roles since 2013, was being moved to another position in the agency.
With the roll out of agentic AI, the US FDA continues to expand its capabilities, following the launch of Elsa, its generative AI tool in May.
CMS may have decided some of the IPAY 2027 drugs did not measure up to their IPAY 2026 therapeutic alternatives, but negotiation parameters also may have played a role in the lower prices negotiated in the latest round compared to the first cycle.
The final guidance for the upcoming third round of the Medicare drug price negotiation process is most notable for the amount left unchanged.
Because combination vaccines remain in the US childhood vaccine schedule, ACIP's reconsideration of hepatitis B vaccine dose timing could impact uptake of other immunizations, Demetre Daskalakis told the Pink Sheet.
Pazdur’s departure just weeks into the job creates more uncertainty for the biopharma industry and an embarrassing situation for Commissioner Martin Makary, who personally lobbied him to take the position.
Pazdur’s departure just weeks into the job creates more uncertainty for the biopharma industry and an embarrassing situation for Commissioner Martin Makary, who personally lobbied him to take the position.
Flu vaccines are specifically mentioned in the CBER director's internal email, but all new and some older vaccines seem to be affected. The impact on development programs is unclear.