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
The CAC solution cleared by the U.S. FDA analyses already existing non-gated CT scans and quantifies the coronary artery calcium in order to identify, stratify, and facilitate treatment pathways for patients with cardiovascular disease
Prostate cancer is the second-most common cancer in men and despite an increase in the number of available treatments for men with mCRPC, five-year survival remains low
Its DirectDetect reagent eliminates RNA extraction for rapid deployment of Covid-19 tests in affected countries
The investment will increase SpeeDx internal capacity to scale up manufacturing
A high-value proposition recyclable film packed with industry-leading barrier and metal bond performance, sustainability quotient and U.S. FDA compliant
This project will be conducted at the “NURA,” a health screening centre that Fujifilm opened in India in February this year
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 pivotal Phase 3 trial achieved all primary endpoints, demonstrating non-inferiority to a leading U.S.-licensed quadrivalent influenza vaccine
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