Agency reviewers looked favorably upon the pivotal trials’ primary efficacy endpoint and low drop-out rate, as well as the overall quality of the NDA submission.
While robust efficacy and a relatively clean safety profile were the basis for FDA approval of Vertex Pharmaceuticals Inc.’s cystic fibrosis drug Kalydeco (ivacaftor), a solid development program unencumbered by problems certainly worked to the company’s advantage, particularly when it came to speeding the compound through the NDA review process.
Agency review documents suggest FDA saw a high-quality development program that generally followed the review division’s advice and produced robust...
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.
Six deaths early in treatment inspired a new safety requirement for Biogen/Eisai’s Leqembi to promote early identification of patients affected by the well-known risk of amyloid-related imaging abnormalities with edema (ARIA-E).
The CBER director rejected Pfizer’s assertions that pediatric dosing gaps, supply constraints and comparative mRNA content justify keeping the vaccine under emergency use authorization for younger children.
The agency is creating two new AI councils to facilitate its role in responsible AI adoption and regulation.
The agency is creating two new AI councils to facilitate its role in responsible AI adoption and regulation.
All COVID-19 vaccines are labeled for individuals 65 years and older or those with risk factors, and Moderna’s Spikevax is the only vaccine indicated for children as young as six months now that Pfizer’s emergency use authorization has been rescinded.
The state’s prescription drug affordability board could be the first to recommend an upper payment limit for a prescription drug.
