The approval marks a major advance in targeted treatment for this rare, chronic autoimmune disease, offering twice-yearly maintenance dosing after two initial loading doses
This approval represents the seventh FDA-approved companion diagnostic indication for PD-L1 IHC 22C3 pharmDx with KEYTRUDA
KEYTRUDA QLEX is contraindicated in patients with known hypersensitivity to its components
Garijo will be the first woman to lead Sanofi in its history
The collaboration is anchored in Syngene’s SynVent platform and Connector model to accelerate promising academic research
The acquisition brings Lilly a novel in vivo cell therapy platform built around engineered circular RNA and proprietary lipid nanoparticles
Pfizer’s anti-infectives portfolio includes both established therapies for moderate to severe infections and newer, clinically robust antimicrobial treatments
The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)
Venglustat, a glucosylceramide synthase inhibitor (GCSi), works by reducing the abnormal buildup of sugar-and-fat molecules in cells and organs
The approval follows the pivotal Phase III ARANOTE trial, which demonstrated that darolutamide plus ADT cut the risk of radiological progression or death by 46% compared to placebo plus ADT
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