The verdict can be an ‘approved’ decision ... as the timeline by which a decision will be given. If the FDA does not mention any timeline, the company may roughly calculate a timeline based ...

The trials presented in the application for FDA approval of Enovid as an oral contraceptive were the largest drug trials ever run. In the trials, 897 women had taken 10,427 cycles of the Pill with ...

Stereotaxis' holistic ecosystem approach aims to solve long-standing issues with robotic adoption in EP. See why STXS stock ...

The FDA approved new COVID-19 vaccines from Pfizer ... Each drug manufacturer during a June meeting with the FDA gave different timelines for when their respective vaccines will be ready.

Despite hotly debated biomarkers and failed or delayed confirmatory trials, the accelerated approval program has a track ...

This is due to the multi-year process, which can lead to multiple opportunities for litigation that may delay timelines set ...

The FDA also used accelerated approval for the initial clearance of asciminib in 2021 for use in CML previously treated with ...