Belzutifan for RCC; AFib Ablation; Roflumilast for Seborrheic Dermatitis; Eflornithine for Neuroblastoma; Isavuconazonium Sulfate For Pediatric Patients; Travoprost Intracameral Implant for Glaucoma; AR Glasses; PD Ablation System; Psychedelics for PTSD

New FDA Approvals

Check out our free downloads at nascentmc.com:

• Implementing AMA Style – 8 Things to Get Right in Your Next Project
• Needs Assessments – 7 Essentials for Getting Funded
• Working With Your Medical Writer – 8 Ways to Get the Most out of Them

See the full write ups for today's episode at nascentmc.com/podcastHere are the highlights:

Belzutifan (Welireg) for RCC:

- FDA approved belzutifan (Welireg) for advanced renal cell carcinoma (RCC) following prior treatments with PD-1/PD-L1 inhibitors and VEGF-TKI. Belzutifan is an HIF-2α inhibitor, the first novel therapeutic class for advanced RCC since 2015. Approval based on phase 3 LITESPARK-005 study data, granted to Merck Inc.

Pulse Field Ablation (PFA) system for AFib:

- FDA approved PulseSelect PFA system for atrial fibrillation (Afib) treatment. PFA uses electrical pulses to ablate cardiac tissue without thermal energy, reducing adverse events. Medtronic Inc. received approval.

Roflumilast 0.3% (Zoryve) for Seborrheic Dermatitis:

- FDA approved roflumilast foam 0.3% (Zoryve) for seborrheic dermatitis in individuals aged 9 and older. This is the first drug with a new mechanism of action for seborrheic dermatitis in over two decades. Approval supported by positive results from the STRATUM phase 3 trial, granted to Arcutis Biotherapeutics, Inc.

Eflornithine (Iwilfin) for Neuroblastoma:

- FDA approved eflornithine (Iwilfin) to reduce the risk of relapse in high-risk neuroblastoma patients. Eflornithine inhibits ornithine decarboxylase, reducing cell growth. Approval based on multi-site study results and granted to US WorldMeds, LLC.

Isavuconazonium Sulfate For Pediatric Patients:

- FDA approved isavuconazonium sulfate (Cresemba) for invasive aspergillosis and mucormycosis in pediatric patients. Provides an alternative to eye drops for glaucoma treatment, offering continuous delivery of travoprost. Approval based on Phase 3 trials and plans for label change, granted to Glaukos.

Augmented Reality Smart Glasses Technology:

- FDA approved NuLoupes augmented reality smart glasses with 3D stereoscopic imaging for dentistry and medicine. Offers live 3D stereoscopic imaging and plans to ship developer kits in 2024. Approval granted to NuEyes.

OneRF Ablation System for Parkinson’s:

- FDA cleared the OneRF Ablation System for neurosurgical procedures in Parkinson's disease and other neurological conditions. Designed to capture electrical activity and selectively destroy brain tissue. Launch planned by NeuroOne in the first half of 2024.

Pimicotinib For Tenosynovial Giant Cell Tumor:

- FDA granted fast track approval to pimicotinib for the treatment of tenosynovial giant cell tumors. Demonstrated an overall response rate of 87.5% in a Phase 1b trial. Manufactured by Abbisko and commercialized in partnership with Merck.

NDA for MDMA-Assisted Therapy for PTSD:

- NDA submitted for MDMA in combination with psychotherapy for PTSD, aiming to be the first psychedelic-assisted therapy approved for PTSD. Submission by MAPS Public Benefit Corporation based on positive Phase 3 clinical trial results. Requested Priority Review of the NDA.