The FDA has delayed granting full approval of Novavax's COVID-19 vaccine despite it being on track to be cleared until ...

Experts discuss survival data from the TiNivo-2 phase 3 trial and practical approaches to dose management in clinical practice.

Solriamfetol is a dopamine and norepinephrine reuptake inhibitor, trace amine-associated receptor 1 agonist, and 5-HT 1A agonist. It is currently approved under the brand name Sunosi ® to improve ...

Following a successful Type B end-of-phase 2 meeting, the FDA has approved the start of a phase 3 trial of linperlisib in peripheral T-cell lymphoma.

Immune response data from FLAMINGO-01 shows positive results in patients with HER2+ breast cancer, suggesting potential for ...

In response to a request from the European Medicines Agency (EMA) following the death of a 16-year-old patient in the U.S., ...

Kaplan–Meier curves showed that extended adjuvant pyrotinib administered after trastuzumab-based adjuvant therapy provides a promising survival benefit in patients with high-risk HER2-positive breast ...

None of the cell and gene therapies that reached the final regulatory submission stage were rejected by the FDA.

The topical ocular drug is an investigational new drug candidate that requires more well-controlled studies to establish ...

On track to announce primary endpoint result from ORIGIN 3 trial this quarter (2Q 2025)U.S. FDA BLA submission for accelerated approval planned ...

Pembrolizumab plus concurrent chemoradiotherapy shows ongoing antitumor activity after about 5 years of follow-up in patients ...

Vera Therapeutics (VERA) announced that it has completed full enrollment in the pivotal ORIGIN Phase 3 trial of atacicept in patients with IgA ...