Glenmark's current portfolio consists of 174 products authorized for distribution in the U.S. marketplace and 48 ANDA's pending approval with the USFDA
While Pregabalin will be manufactured at the Aurangabad facility, Iloperidone will be manufactured at the Goa facility
Diana is a senior leader with more than 38 years of field experience in U.S. FDA’s Office of Regulatory Affairs (ORA)
Biocon Biologics’ Insugen formulations will be available to patients at all Ministry of Health hospitals, district health offices and health clinics
Erytech is evaluating valuable strategic options to leverage its Erycaps platform and its development and manufacturing capabilities with complementary assets and/or a broader corporate transaction
If approved, it will be the first USFDA-approved immunomodulator for the treatment of Covid-19 in hospitalised patients
A novel second-generation approach to achieve a safe, durable, and stable transgene expression to overcome the challenges of factor VIII replacement therapies
50 µg dose approved for all adults over 50 years of age and immunocompromised adults over 18 years of age
The company plans to launch the product immediately
The studies demonstrate a standardized strategy to extend mechanistic modeling and systems pharmacology into drug safety and mode of action assessments that has relevance for drug development and a variety of other contexts
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