Berdazimer for Molluscum Contagiosum; Pembrolizumab for Cervical Cancer; GLP-1 RAs and Suicidal Thoughts; Cognitive Impairment Test; SH-105 for Breast and Ovarian Cancer; DBS System for Parkinson’s; NexoBrid for Pediatric Burns; Laser Platform for LASIK

New FDA Approvals

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Summary:

§ FDA has approved berdazimer topical gel, 10.3% (Zelsuvmi), as the first novel drug for molluscum contagiosum, a viral skin infection affecting adults and children over 1 year old.

§ Pembrolizumab (Keytruda) is now approved for stage III-IVA cervical cancer treatment in combination with chemoradiotherapy, based on positive data from the KEYNOTE-A18 trial. It's the third indication for cervical cancer and 39th overall

§ The FDA issued a drug safety communication regarding GLP-1 receptor agonists and suicidal thoughts, finding no clear relationship between them.

§ BrainSee, a noninvasive test, approved for predicting progression from amnestic mild cognitive impairment (aMCI) to Alzheimer's dementia using MRI and cognitive assessments, offering a same-day alternative to traditional methods.

§ SH-105, a novel treatment for breast and ovarian cancers, had its NDA accepted with a target action date set for June 29, 2024, offering a differentiated injectable product.

§ Medtronic's Percept RC deep brain stimulation system received FDA approval for Parkinson's.

§ NexoBrid, a topically administered biological product for burn treatment, expanded its label to include pediatric patients based on positive results from clinical trials.

§ The FDA approved the Teneo excimer laser platform for LASIK surgery, featuring high-speed eye tracking and fast ablation times for precise vision correction in individuals aged 22 and older. See full write up and supporting links at nascentmc.com/podcast.