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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
Manage episode 421770870 series 3561458
Go here for complete show notes.
Visit learnAMAstyle.com for free downloads on medical writing and editing
Nascentmc.com for medical writing assistance for your company.
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.
60 episodes
Manage episode 421770870 series 3561458
Go here for complete show notes.
Visit learnAMAstyle.com for free downloads on medical writing and editing
Nascentmc.com for medical writing assistance for your company.
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.
60 episodes
Kaikki jaksot
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