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
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
VYVGART was well tolerated, with a safety profile consistent with prior studies in AChR-Ab seropositive gMG and other indications
New manufacturing facility in Mebane to produce at least 40 million laboratory pipette tips per week
The safety profile in alopecia areata was generally consistent with that in approved indications, and no new safety signals were identified in this study
The accelerated approval is supported by results from part 1 of the ESSENCE trial
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