By Ramsey Baghdadi
The Food & Drug Administration's top priority for the re-review of GlaxoSmithKline's diabetes drug Avandia is to deliver a credible...
Going into the Avandia re-review, FDA looked stuck between a rock and a hard place. Coming out of the FDA advisory committee meeting, the agency has a full set of options to choose from that would likely be viewed as a credible outcome by the public. But possible surprises remain.
By Ramsey Baghdadi
The Food & Drug Administration's top priority for the re-review of GlaxoSmithKline's diabetes drug Avandia is to deliver a credible...
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.
It is unclear in a revised staff manual guide whether Commissioner's National Priority Voucher program approval “recommendations” from the drug and biologic center directors will be advisory or decisional, experts told the Pink Sheet.
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.