The FDA also expanded Repatha’s use as monotherapy to include patients with homozygous familial hypercholesterolemia
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 product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), VASOSTRICT Injection 40 Units per 100 mL and 20 Units per 100 mL of PH Health Limited
This project shall be implemented through incorporation of a new joint venture company in Zambia
Dawnzera demonstrated significant and sustained HAE attack rate reduction and long-term disease control
The safety profile in alopecia areata was generally consistent with that in approved indications, and no new safety signals were identified in this study
Astaxanthin is a powerful antioxidant and red-orange carotenoid pigment found in various aquatic organisms
Vivo Bio Tech will have end-to-end responsibility for conducting the full spectrum of pre-clinical safety and regulatory studies
NATCO holds the first-to-file status for this product and will have 180-day generic drug exclusivity
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