argenx reports positive phase 3 ADAPT SERON results of VYVGART in AChR-Ab seronegative gMG
VYVGART was well tolerated, with a safety profile consistent with prior studies in AChR-Ab seropositive gMG and other indications
VYVGART was well tolerated, with a safety profile consistent with prior studies in AChR-Ab seropositive gMG and other indications
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
New manufacturing facility in Mebane to produce at least 40 million laboratory pipette tips per week
As part of its partnership with Dr. Reddy’s Laboratories (DRL), FDA acceptance also triggers a $4.2 million milestone payment to Coya
The US generic market is crucial for Indian pharma, contributing about 35% to its total revenue, around US$ 10.7 billion
AiMeD noted that proposed GST changes—to either 5% or 18%—both present significant risks requiring carefully nuanced consideration
The inspection, conducted from June 23 to June 25, 2025, concluded with zero Form 483 observations
Delegates also visited Emami’s WHO-GMP-certified manufacturing plant and Zandu Foundation for Healthcare farms for hands-on exposure to quality practices,
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