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
As part of its partnership with Dr. Reddy’s Laboratories (DRL), FDA acceptance also triggers a $4.2 million milestone payment to Coya
This authorization follows FDA approval in June and WHO’s July recommendation adding twice-yearly lenacapavir as a PrEP option
The US generic market is crucial for Indian pharma, contributing about 35% to its total revenue, around US$ 10.7 billion
The inspection, conducted from June 23 to June 25, 2025, concluded with zero Form 483 observations
Delegates also visited Emami’s WHO-GMP-certified manufacturing plant and Zandu Foundation for Healthcare farms for hands-on exposure to quality practices,
Protein L is known as a “superantigen” because it can bind antibodies in unusual ways
Terufusion Advanced Infusion Systems combine a smart syringe pump, smart infusion pump, and pump monitoring system software for precise and efficient drug administration
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