Alkermes has reported positive top line data from the Phase III REVITALYZ study, assessing the investigational use of extended-release Lumryz oral suspension in adults with IH.

This new high dose Wegovy data could help support Novo Nordisk in its bid to claw back market share taken by Eli Lilly in the obesity space.

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

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

Gene Therapeutics has reported additional interim outcomes from its ongoing LEGEND Phase II trial assessing detalimogene voraplasmid for BCG-unresponsive NMIBC.

Despite a patient death, WhiteSwell is moving forward with its plans to conduct the randomised LYMPH-HF trial on its eLym system in ADHF.

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.

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

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