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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
Adults infected with the Omicron variant are 29 percent less likely to enter the hospital than people infected with other COVID-19 strains, according to the first large-scale real-world clinical data. Read More
The ICMRA set up the working group to review the adaptation of both good clinical practice (GCP) and good manufacturing practice (GMP) inspections during the COVID-19 pandemic to remote approaches. Read More
Stanton, Calif.-based Sanitor Corporation has drawn an FDA warning letter over current good manufacturing practice (cGMP) violations for finished drugs. Read More
Sanofi and GlaxoSmithKline (GSK) said preliminary data from a phase 3 study showed that a booster dose of their experimental COVID-19 shot induces strong immunity but said they won’t release full trial results until early next year. Read More
Did Gilead Sciences collude with other drug companies to delay its blockbuster HIV pills from reaching the end of their patents? Did the company offer sweet deals to a generic drugmaker to keep it from coming to market with much more affordable versions of Gilead’s HIV drugs? 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
The FDA said it doesn't intend to take enforcement action against sponsors or healthcare providers with respect to the risk evaluation and mitigation strategy (REMS) that requires them to have two doses of tocilizumab on hand for CAR-T cell infusion patients. Read More