FDA expands Repatha indication to adults at risk of major cardiovascular events from uncontrolled LDL-C
The FDA also expanded Repatha’s use as monotherapy to include patients with homozygous familial hypercholesterolemia
The FDA also expanded Repatha’s use as monotherapy to include patients with homozygous familial hypercholesterolemia
The new lineup includes CereTom Elite, OmniTom Elite, OmniTom Elite PCD, and BodyTom 32/64
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
AiMeD noted that proposed GST changes—to either 5% or 18%—both present significant risks requiring carefully nuanced consideration
Delegates also visited Emami’s WHO-GMP-certified manufacturing plant and Zandu Foundation for Healthcare farms for hands-on exposure to quality practices,
Merck will share two oral presentations on ASCVD treatment patterns and patient burden
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