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
As part of this strategic partnership, LTI with its digital, technical and life sciences domain capabilities, will help accelerate joint go-to-market pursuits and faster deployment for Clinpal Adopters
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
ZyCoV-D is the first DNA plasmid vaccine in the world for human use, developed indigenously by the company against the Covid-19 virus
The company does not expect the outcome of this inspection to impact its plans
It is a recombinant nanoparticle protein-based vaccine
Zydus' Apremilast tablets are indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
saRNA is a new platform for the development of medicines and vaccines which uses similar technology to mRNA but with the added ability to self-amplify, thereby expressing proteins for longer, resulting in higher protein levels per dose level
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
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