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As the FDA unveils a parade of initiatives aimed at accelerating drug development for rare diseases, experts appeal for a consistent approval process that will support and further catalyze momentum.

Innovative outcome measures coupled with a focus on patient-centered clinical differentiation can help the biopharma industry make meaningful progress in the highly complex area of neuroscience.

Swan highlighted Todd’s experience in scaling robotic platforms, building global engineering organizations and driving innovation across endoscopy and minimally invasive surgery.

Panelists focused on study data that showed the implant did not improve outcomes in heart failure patients.

The CVS-owned payer is working to bundle multiple prior authorizations for certain conditions into one single review.

Although the strategy is internally focused to start, the agency said it will collaborate with the private sector and identify “priority” conditions and health issues that could be addressed with AI tools. 

Commissioner Marty Makary said that the FDA will soon start requiring only one pivotal trial, instead of two, for companies seeking approval for new drugs.

Hypersensitivity reactions in a mouse model prompted the agency to suspend Denali’s planned Phase I development for DNL952 for Pompe disease.

The ACIP decided 6–3 to postpone its vote on hepatitis B vaccination changes after the language of the questions was repeatedly changed in the days leading up to the meeting.

Praxis has also announced a “successful” pre-NDA meeting with the FDA for its essential tremor drug candidate ulixacaltamide, for which an approval application is slated for early 2026.