mRESVIA for Lower Respiratory Tract Disease, Breyanzi for R/R MCL, Sarclisa for ND MM, Onyda XR for ADHD, Bkemv for PNH and aHUS, Austedo in Huntington’s

New FDA Approvals

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mRESVIA for Lower Respiratory Tract Disease

The FDA approved mRNA-1345 (mRESVIA) for preventing RSV-caused lower respiratory tract disease in adults 60 and older, based on Phase 3 trial results showing 83.7% efficacy and no serious safety concerns.

Breyanzi for R/R MCL

The FDA approved lisocabtagene maraleucel (Breyanzi) for treating relapsed or refractory mantle cell lymphoma (MCL) after at least two prior therapies, demonstrating an 85.3% overall response rate in trials.

Sarclisa for ND MM

The FDA accepted the sBLA for isatuximab (Sarclisa) combined with VRd for treating transplant-ineligible newly diagnosed multiple myeloma, showing significant improvement in progression-free survival.

Onyda XR for ADHD

The FDA approved clonidine hydrochloride (Onyda XR) for treating ADHD in pediatric patients aged 6 and older, as a liquid nonstimulant medication with common side effects like somnolence and sedation.

Bkemv for PNH and aHUS

The FDA approved eculizumab-aeeb (Bkemv) as the first interchangeable biosimilar to eculizumab for treating PNH and atypical hemolytic uremic syndrome, requiring meningococcal vaccination prior to use.

Austedo in Huntington’s

The FDA approved a new once-daily tablet option for deutetrabenazine (Austedo XR) for tardive dyskinesia and chorea in Huntington's disease, enhancing treatment flexibility and adherence based on long-term safety and effectiveness data.