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
Treatment with Verzenio also resulted in sustained invasive disease-free survival and distant relapse-free survival benefit
Accro will retain global rights to develop, manufacture, and commercialize AC-201 (excluding Chinese Mainland, Hong Kong SAR, and Macau SAR)
As with any medicine, the MHRA will keep the safety of gepotidacin under close review
Merger is expected to streamline operations and provide unified management focus, driving efficiency and strategic alignment
Generic Saxenda is the first-ever generic GLP-1 indicated for weight loss, addressing increased demand for this category of therapies in the US market
WIDAPLIK is the first and only FDA-approved triple combination medication for use as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals
Triggering global regulatory submissions this year for the treatment of obesity
The updated formula for Spikevax is now approved for individuals 6 months through 64 years of age
Saroglitazar was generally well tolerated, with overall adverse events generally balanced between Saroglitazar-treated and placebo-treated patients
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