Biotech | October 01, 2021
Jubilant concludes pre-IND meeting of JB1-802 with U.S. FDA
The company plans to submit the IND application by the end of 2021
The company plans to submit the IND application by the end of 2021
According to industry sales data, the 10mg strength of Afinitor generated annual sales of US $ 392 million during the twelve months ending July 2021
If cleared, Merck's drug would be the first pill shown to treat Covid-19, a potentially major advance in efforts to fight the pandemic
The BLA is being submitted under the accelerated approval pathway and is primarily based on clinical, biomarker and safety data from the Phase 2b clinical trial in people with early AD and confirmed amyloid pathology
It is the first orally administered therapy for the treatment of two types of ANCA-associated vasculitis approved in Japan
The FDA also approved Repatha as an adjunct to other LDL-C lowering therapies for the treatment of homozygous familial hypercholesterolemia (HoFH) for younger pediatric patients
The company does not expect the outcome of this inspection to impact its plans
The NanoDrop Eight simultaneously evaluates eight samples in 20 seconds or less and the instrument can also measure high-concentration samples of up to 200 absorbance units without dilution
Emergency Use Authorisation (EUA) is granted for individuals 65 years of age and older, and individuals ages 18 through 64 within certain high-risk groups
It becomes the first ophthalmology biosimilar to gain FDA approval in the United States
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