The filing includes data from PROVENT Phase III trial showing 77% reduction in risk of developing symptomatic Covid-19 with a long-acting antibody combination (non-vaccine)
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
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
One of the key factors driving the market growth is the rise in the occurrence of chronic cardiovascular diseases such as heart failure and coronary artery disease: Valuates Reports
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
Advancement to Phase 3 is a major milestone for SAB’s unique DiversitAb immunotherapy platform that produces fully human polyclonal antibodies without human donors
The pivotal Phase 3 trial achieved all primary endpoints, demonstrating non-inferiority to a leading U.S.-licensed quadrivalent influenza vaccine
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
Ampion is directly administered by inhalation and it allows the drug to directly target and attenuate inflammation in the lungs
It becomes the first ophthalmology biosimilar to gain FDA approval in the United States
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