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
Ampion is directly administered by inhalation and it allows the drug to directly target and attenuate inflammation in the lungs
The bank will provide a complete range of financing options including hospitals, labs, diagnostic centres and equipment manufacturers
It becomes the first ophthalmology biosimilar to gain FDA approval in the United States
If approved, Gavreto will be the first and only targeted treatment approved by the EMA that includes first-line treatment of people with RET fusion-positive advanced NSCLC
The recommendation is based on positive results from the pivotal Phase 3 CheckMate -649 trial in which Opdivo plus chemotherapy demonstrated superior overall survival versus chemotherapy
Data show the vaccine regimen induced neutralising antibody responses in nearly all participating adults and children 21 days after the second dose. Adults receiving booster shots two years after the initial vaccination regimen showed strong immune responses
This clinical study demonstrated that the 14-day regimen of ImmunoSEB and ProbioSEB CSC3 resolved post-Covid-19 fatigue symptoms and improved patients' functional status and quality of life
The designation is based on results from the EMPEROR-Preserved phase III trial, which established Jardiance as the first therapy to show statistically significant improvement in heart failure outcomes in adults with heart failure with a preserved ejection fraction
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