FDA Approves Hibsago, a First-of-Its-Kind Hepatitis B Drug That Lets Some Patients Stop Treatment
The FDA has approved Hibsago (bepirovirsen), GSK's injectable antisense drug for chronic hepatitis B. In two phase 3 trials, about 19% of patients achieved a functional cure and could stop all treatment. The drug carries a boxed warning for liver reactions and low platelets.
FDA Grants Accelerated Approval to Dostarlimab for dMMR Rectal Cancer, Opening a Path Around Surgery
The FDA has cleared GSK's immunotherapy Jemperli for a small, genetically defined group of patients with locally advanced rectal cancer. In trials, many avoided surgery, radiation and chemotherapy entirely, but the evidence comes from single-arm studies and longer follow-up is still required.
The Antiseptic Needed an Antiseptic: Kits With Recalled ChloraPrep Applicators Get the FDA’s Most Serious Recall Rating
Hospitals must now destroy entire Medline and AVID Medical kits containing recalled BD ChloraPrep applicators after the FDA assigned its most serious recall rating over possible fungal contamination.
The FDA Promises a Custom-Fit Rulebook for Rare Disease Drugs. Patients Should Read the Fine Print.
The FDA’s new Rare Disease Framework Initiative promises evidence standards tailored to tiny patient populations. What it covers, how to weigh in on October 28, and the questions it leaves open.