Drug Approval | August 31, 2025
FDA suspends Valneva’s license of chikungunya vaccine IXCHIQ in US
The sudden subsequent decision to suspend IXCHIQ is based on updated VAERS data
The sudden subsequent decision to suspend IXCHIQ is based on updated VAERS data
The study showed a significant 29% reduction in the risk for heart attack, stroke and death from any cause in the Wegovy users
Nuvaxovid is the only protein-based, non-mRNA COVID-19 vaccine available in the U.S. for the 2025-2026 vaccination season
Treatment with Verzenio also resulted in sustained invasive disease-free survival and distant relapse-free survival benefit
Triggering global regulatory submissions this year for the treatment of obesity
Saroglitazar was generally well tolerated, with overall adverse events generally balanced between Saroglitazar-treated and placebo-treated patients
VYVGART was well tolerated, with a safety profile consistent with prior studies in AChR-Ab seropositive gMG and other indications
This authorization follows FDA approval in June and WHO’s July recommendation adding twice-yearly lenacapavir as a PrEP option
Dawnzera demonstrated significant and sustained HAE attack rate reduction and long-term disease control
The safety profile in alopecia areata was generally consistent with that in approved indications, and no new safety signals were identified in this study
Subscribe To Our Newsletter & Stay Updated
