Dr Robert Sikorski shares his experience working with the FDA, saying its technical staff remain knowledgeable and dedicated despite recent changes.

As enthusiasm around AI continues to grow, the conversation is shifting from theoretical potential to practical implementation.

This FDA framework comes as significant knowledge gaps remain around the efficacy and safety of drugs in pregnancy and lactation.

Actio Biosciences has begun the KYRON Phase Ib/II trial of ABS-1230, a selective oral KCNT1 inhibitor, for KCNT1-related epilepsy.

Day One Biopharmaceuticals has concluded patient enrolment in the Phase III FIREFLY-2 trial assessing tovorafenib for pLGG.

Taimei Technology and South Korea’s C&R Research have partnered to co-develop an AI-powered clinical trial operations system.

Nocion Therapeutics has completed patient enrolment in its Phase IIb ASPIRE study assessing taplucainium as a treatment for rCC/uCC.

Alebund Pharmaceuticals has completed patient enrolment in its global Phase III pivotal clinical trial of AP301 for hyperphosphatemia.

ENTR-601-44 didn’t elevate dystrophin levels to analyst expectations, or to the baseline change recorded by Novartis’ del-zota.

Google Ventures-backed Iterative will now expand its platform into burgeoning therapeutic areas like cardiology and obesity.

Viridian is in the process of filing a BLA for its TED candidate elegrobart based on two positive Phase III trials.

After two years, there was an 87% reduction in death in ALS patients treated with Corcept's dazucorilant compared with those who received placebo.