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 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
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