Visit nascentmc.com to get medical writing assistance for your company. Visit learnAMAstyle.com for free downloads about medical editing and writing in the AI era. See full write up and supporting links for this episode at nascentmc.com/podcast.
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.
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By Emma Hitt Nichols, PhD
5
44 ratings
Visit nascentmc.com to get medical writing assistance for your company. Visit learnAMAstyle.com for free downloads about medical editing and writing in the AI era. See full write up and supporting links for this episode at nascentmc.com/podcast.
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.
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