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The FDA has issued a Deferred Action letter for Amicus Therapeutics’ biologic license application (BLA) for cipaglucosidase alfa, the biologic component of AT-GAA, its investigational dual therapy for muscle-wasting Pompe disease. Read More
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 has declined to green-light Gilead Sciences’ hepatitis delta virus (HDV) drug bulevirtide because of manufacturing and delivery concerns, meaning there will continue to be no approved treatment for the condition in the U.S. 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