At the end of the current inspection, a 'Form 483' was issued with 5 observations which are procedural in nature and no data integrity issues were reported
The study showed a significant 29% reduction in the risk for heart attack, stroke and death from any cause in the Wegovy users
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
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
Merger is expected to streamline operations and provide unified management focus, driving efficiency and strategic alignment
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