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The European Medicines Agency’s (EMA) human medicines committee endorsed granting 13 marketing authorizations for drugs during its monthly meeting, held Dec. 13 to 16. Read More
Calliditas Therapeutics’ Tarpeyo (budesonide) has won FDA accelerated approval for reducing a harmful urine protein in adults with a rare kidney disease, primary immunoglobulin A (IgA) nephropathy. Read More
After a year of controversy for janus kinase (JAK) inhibitors, the FDA has now greenlighted two JAK inhibitors for inflammatory disease indications that had been delayed for months while the agency reviewed the class of drugs for safety concerns. Read More
Evusheld’s EUA was supported by data from a phase 3 study, which showed the combination reduced the risk of developing symptomatic COVID-19 by 77 percent vs. placebo. Read More
The FDA has revised Pfizer/BioNTech’s Emergency Use Authorization (EUA), allowing a booster of the companies’ COVID-19 vaccine in teenagers aged 16 and 17 six months following completion of a primary vaccination series. Read More
An FDA advisory committee unanimously rejected recommending approval of Reata Pharmaceuticals’ bardoxolone methyl as a treatment for patients 12 years and up with chronic kidney disease caused by Alport syndrome (AS), a rare genetic disorder. Read More
The WHO said the evidence was less certain for severe and critically ill COVID-19 patients and suggested trials continue for this subgroup to gather more data. Read More