Agency already had an action plan in hand to address concerns with the aducanumab review even before the controversial approval, but it has not been fully implemented yet. A House committee report is another nudge.
The US Food and Drug Administration has several policy updates planned to address elements of the controversial review of Biogen, Inc./Eisai Co., Ltd.’s Aduhelm, but the timeline for the agency to finally implement them remains unclear.
That’s among the revelations from a House report investigating the approval of the Alzheimer’s treatment, which recommended that FDA...
Recent studies show that spaceflight can significantly weaken astronauts’ immune systems, making them more susceptible to infections and health complications during and after missions. Understanding these changes is crucial for ensuring the safety of future long-duration space travelers.
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
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