The positive benefit-risk profile of vericiguat in its approved indication in patients with HFrEF following a recent heart failure event based on the pivotal Phase III VICTORIA trial remains unchanged
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
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
The inspection, conducted from June 23 to June 25, 2025, concluded with zero Form 483 observations
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