The NDA submission included data from the STRIVE-ON trial, which compared GTx-104 with oral nimodipine in patients hospitalized with aSAH.

Supported by the CHORD trial, this AAV vector-based therapy delivers a working copy of the OTOF gene and restores otoferlin protein production.

The PIONEER TEENS trial compared oral semaglutide at maximum tolerated doses with placebo in adolescents aged 10 to 17 years with T2D.

The expanded approval was based on data extrapolated from Study A, B, and C of the LIBERTY-CUPID program and supportive pharmacokinetics data from the single-arm CUPIDKids study.

A new effort to prepare for future bird flu outbreaks is moving forward, despite a major funding setback. The American pharmaceutical and biotechnology company Moderna has initiated a large clinical ...

"I’m not going to make that kind of commitment," replied CDC director Kennedy when asked if he'd support vaccine guidance from Dr Schwartz. HealthDay News — During a tense congressional hearing ...

Sources familiar with the decision who spoke to The Post anonymously said the report had passed the CDC’s scientific review before the delay.

The expanded approval was based on the single-arm, non-randomized, open-label phase 4 PETITE-T1D study, which evaluated the safety and pharmacokinetics of teplizumab.

By targeting underlying synovitis, the novel intra-articular liraglutide formulation 4P004 aims to bridge the gap between transient symptom relief and disease modification in knee OA.

Idvynso is a new once-daily, two-drug oral regimen for adults with HIV-1 who are virologically suppressed and have no history of treatment failure.

Dr Erica Schwartz, nominated to lead the US Centers for Disease Control and Prevention, is highly qualified, according to ...

Treatment with daraxonrasib significantly improves progression free survival and overall survival in patients with previously treated metastatic pancreatic ductal adenocarcinoma. Topline results were ...