Drug Approval | August 27, 2021
Aurobindo subsidiary, Eugia gets US FDA approval for Cyclophosphamide injection
The product will be available in 500 mg/2.5 mL and 1 g/5 mL vials
The product will be available in 500 mg/2.5 mL and 1 g/5 mL vials
The manufacture of finished doses will commence in 2022 and at full operational capacity, the annual production is expected to exceed 100 million doses annually
New interim data from these studies demonstrate that a booster dose of the Johnson & Johnson Covid-19 vaccine generated a rapid and robust increase in spike-binding antibodies, nine-fold higher than 28 days after the primary single-dose vaccination.
The submission to the US FDA has been initiated and they intend to file these data with the European Medicines Agency and other regulatory bodies in the coming weeks
Opaganib, a leading novel small molecule investigational oral pill in development for Covid-19, is a unique host targeted, dual antiviral and anti-inflammatory drug that acts on the cause and effect of the disease
The Evolut FX TAVR system is used for treatment of symptomatic severe aortic stenosis and it has features that enhance ease-of-use and predictable valve deployment
When the Delfi technology was used as a pre-screen to determine if a low dose CT (LDCT), should be performed, the combined approach led to the detection of 90% of lung cancers, including 80% of stage I cancers
The vaccine will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of Covid-19 disease
The acquisition was expected to be completed in eight weeks, and it would have provided it with a foothold in the US $ 48 billion global animal health market
New treatment options are critical, as approximately half of all people with heart failure die within five years of diagnosis. Heart failure accounts for more than one million hospitalisations a year in the US
Subscribe To Our Newsletter & Stay Updated
