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
This authorization follows FDA approval in June and WHO’s July recommendation adding twice-yearly lenacapavir as a PrEP option
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
The inspection, conducted from June 23 to June 25, 2025, concluded with zero Form 483 observations
The complex four-hour surgery was performed by a multidisciplinary team of doctors
The first pillar is advanced manufacturing, focused on upgrading existing CDMO
Protein L is known as a “superantigen” because it can bind antibodies in unusual ways
Guidelines aim to establish state-regulated veterinary blood banks
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