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Use of FDA’s expedited approval pathways for new drugs increased from 42 percent in 2008 to more than 75 percent in 2021 — an increase that’s likely to continue as innovative biologic therapies targeting rare diseases seek marketing approval, according to a team of senior FDA officials that recommends the agency exercise caution in speeding new drug approvals. Read More
The EMA panel recommended that JAK inhibitors be used cautiously, if at all, in patients who are age 65 years and older, at increased risk of major cardiovascular problems, past and current smokers or those with a history of cancer. Read More
The FDA clarifies its regulatory requirements for small entity establishments that manufacture human cells, tissues, or cellular or tissue-based products (HCT/P), in a final guidance released today. Read More
In a draft guidance released today, the FDA says trials of drugs for pediatric use should train clinical investigators and trial staff to measure and evaluate the drug’s potential impact on participants’ physical growth and sexual development. Read More
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’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