Eplontersen for ATTR-CM, Nivolumab for NSCLC, RSV Vaccine for Adults Aged 50 to 59, Spinal Cord Stimulation System for NSBP, OK-101 for Neuropathic Corneal Pain, Viz ICH Plus for Brain Bleed, Vepdegestrant for MBC, VerTouch Spinal Puncture Device

New FDA Approvals

Visit nascentmc.com/podcast for full show notes

[free course] ChatGPT4 in medical writing and editing at learnAMAstyle.com

Nascentmc.com for medical writing assistance for your CME or Medical Communications company.

Eplontersen for ATTR-CM Eplontersen received FDA Fast Track designation for treating transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) in adults, aiming to inhibit TTR protein production. Nivolumab for NSCLC The FDA accepted supplemental applications for nivolumab in resectable stage 2A to 3B non-small cell lung cancer (NSCLC) based on the CheckMate-77T trial showing improved survival rates.

RSV Vaccine for Adults Aged 50 to 59 The FDA prioritizes review of GSK's Arexvy vaccine for RSV in adults aged 50-59 at risk of complications, expanding from its existing approval for those 60 and older.

Spinal Cord Stimulation System The FDA approved Boston Scientific's WaveWriter Spinal Cord Stimulation Systems for chronic low back and leg pain treatment in non-surgery patients, based on the SOLIS trial results.

OK-101 for Neuropathic Corneal Pain The FDA approved an IND application for OK-101, a first for treating neuropathic corneal pain (NCP), an Orphan disease, developed by OKYO Pharma Limited.

Viz ICH Plus for Brain Bleed The FDA cleared Viz ICH Plus, an AI algorithm by Viz.ai for automating the identification and quantification of brain bleeds and structures in NCCT images.

Vepdegestrant for MBC Vepdegestrant received FDA Fast Track designation for treating ER-positive/HER2-negative advanced or metastatic breast cancer in patients previously treated with endocrine therapy. VerTouch Spinal Puncture Device The FDA cleared VerTouch, a handheld imaging tool by IntuiTap Medical, designed to improve the accuracy of spinal punctures by providing a 2D image of lumbar spinal anatomy.