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Older people, smokers and those with an increased risk of cardiovascular problems shouldn’t use Janus kinase inhibitors for chronic inflammatory diseases unless there are no other suitable treatment options, according to new recommendations by the European Medicines Agency (EMA). Read More
The FDA has rejected a citizen petition pressing the agency to revoke the accelerated approval for Jazz Pharmaceuticals’ and PharmaMar’s Zepzelca (lurbinectedin), a treatment for adults with metastatic small cell lung cancer (SCLC). Read More
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 16-0 on Friday against recommending Y-mAbs Therapeutics’ biologic candidate for the treatment of central nervous system/leptomeningeal (CNS/LM) metastases in children with neuroblastoma who have had the standard treatment for CNS disease. Read More
As the FDA’s decision date on GSK’s new drug application (NDA) for daprodustat — its chronic kidney disease anemia drug candidate — approaches, an FDA advisory panel said Wednesday that it favors the drug for kidney patients on dialysis but not for patients who aren’t. Read More
The FDA is falling under the political spell that “more drugs, and faster” is the best way to serve the healthcare needs of American citizens, according to a new report that also criticizes the agency’s lack of transparency and reliance on industry funding. Read More
In a new draft guidance released Thursday, the FDA laid out its thinking on developing drugs that treat Clostridioides difficile infection (CDI), as well as those that prevent and reduce recurrence of the condition. Read More