Drug Approval | October 14, 2021
IOL receives Korean FDA approval
The company’s pharmaceutical API products Ibuprofen and fenofibrate got the go-ahead
The company’s pharmaceutical API products Ibuprofen and fenofibrate got the go-ahead
Conventional Itraconazole mainstay drug to fight fungal infection has high result variance and low patient compliance because of dosing dependence upon food, acidic beverage and antacid consumption
The company has enabled a transformation across three core areas with an investment target of US $ 150 million
The rolling submission to the U.S. FDA will begin in the fourth quarter of this year
The applicants will only have to get their Good Manufacturing Practices certification validated every five years to retain their licence
The first study to investigate the safety and immunogenicity of both vaccines when co-administered compared to each vaccine administered separately in adults aged 65 years and older
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
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