The New FDA Approvals podcast is a weekly podcast that aims to help clinicians, medical writers, and pharmaceutical industry executives stay up to date on the latest FDA approvals. Join Dr. Emma Hitt Nichols each Monday morning for an update on the previous week’s FDA activities.
039 — Lifileucel for Melanoma, Iloprost Injection for Frostbite, MDMA-Assisted Therapy for PTSD, NALIRIFOX for Pancreatic Cancer, Tepotinib for NSCLC, Omalizumab for Food Allergies, Budesonide Oral Suspension for EOE, TriClip® for Tricuspid Regurgitation, ACE2016 for Solid Tumors, Human Acellular Vessel (HAV) for Vascular Trauma
00:00:00 Here is information on the latest US FDA approvals, the week of February 12 – February 16, 2024 Amtagvi for Melanoma The FDA has granted accelerated approval of lifileucel (Amtagvi) for adult patients with unresectable metastatic melanoma previously treated
038 — 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
Here is information on the latest US FDA approvals for the week of February 5–9, 2024 Eplontersen for ATTR-CMEplontersen (Wainua) has been granted Fast Track designation by the FDA for the treatment of transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) in adults. Eplontersen,
037 — Tricuspid Valve Replacement System, Afami-Cel for Synovial Sarcoma, Pulsed Field Ablation for Atrial Fibrillation, Shorter Turnaround Time for Axi-cel, AI Algorithm for Cervical Cancer, Trastuzumab Deruxtecan for Solid Tumors
Here is information on the latest US FDA approvals for the week of January 29 – February 2, 2024 Tricuspid Valve Replacement System for Tricuspid Regurgitation The FDA has approved the Evoque tricuspid valve replacement system for the treatment of
036 — Boxed Warning for CAR-T Cell Therapy, Dupilumab for Pediatric EOE, Wearable Device for Osteopenia, BSI-082 IND for Solid and Liquid Tumors, VCA-894A for Charcot Marie-Tooth, FDA Roundup
Here is information on the latest US FDA approvals, the week of January 22 – January 26, 2024 Nascentmc.com ChatGPT4 in medical writing and editing—visit learnAMAstyle.com com for medical writing assistance for your company. Boxed Warning for CAR-T Cell Therapy
035 — Erdafitinib for Urothelial Carcinoma, TTFields in NSCLC, AI-Powered Device to Detect Skin Cancer, Casgevy for Beta Thalassemia, HyQvia for CIDP, Physicians’ Understanding of FDA Approval Process
Here is information on the latest US FDA approvals for the week of January 15 – January 19, 2024 Erdafitinib for Urothelial CarcinomaThe FDA has granted full approval to erdafitinib (Balversa) for treating adult patients with locally advanced or metastatic
034 — 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
Here is information on the latest US FDA approvals, the week of January 8 – January 12, 2024 Berdazimer for Molluscum ContagiosumThe FDA has approved berdazimer topical gel, 10.3% (Zelsuvmi), as the first novel drug for treating molluscum contagiosum in
033 — FDA Approves First State Request to Import Drugs From Canada and 5 Upcoming FDA Approvals
No approvals this week, but I’ll talk about a couple of upcoming things that may be of interest. FDA approves first state request to import drugs from Canada and 5 upcoming FDA approvals FDA approves first state request to import
032 — Potentially Practice-Changing Drugs Approved by the FDA in 2023
https://www.pharmacytimes.com/view/eleven-potentially-practice-changing-drugs-were-approved-by-the-fda-in-2023 Daprodustat (Jesduvroq; GSK) is an oral medication for treating anemia in adults undergoing hemodialysis due to chronic kidney disease (CKD). Unlike traditional treatments that rely on iron supplementation and erythropoiesis-stimulating agents (ESAs), Daprodustat stimulates red blood cell production
031 — Test for Opioid Addiction; Filsuvez for Epidermolysis Bullosa; Budesonide for IgAN; Eplontersen for hATTR-PN; NRX-101 for complicated UTI; Gefapixant for Chronic Cough; V116 for Invasive Pneumococcal Disease; Sotorasib in NSCLC
Here is information on the latest US FDA approvals, the week of December 16 – December 22, 2023. Test for Risk of Opioid Addiction The FDA has approved the first test to assess if there is a risk of opioid