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…

Continue Reading039 — 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

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, 2024Eplontersen for ATTR-CMEplontersen (Wainua) has been granted Fast Track designation by the FDA for the…

Continue Reading038 — 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

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…

Continue Reading037 — 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

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, 2024Nascentmc.comChatGPT4 in medical writing and editing—visit learnAMAstyle.comcom for medical writing assistance for your…

Continue Reading036 — 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

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, 2024Erdafitinib for Urothelial CarcinomaThe FDA has granted full approval to erdafitinib (Balversa)…

Continue Reading035 — 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

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),…

Continue Reading034 — 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

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…

Continue Reading033 — FDA Approves First State Request to Import Drugs From Canada and 5 Upcoming FDA Approvals

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…

Continue Reading032 — Potentially Practice-Changing Drugs Approved by the FDA in 2023

030 — 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

Here is information on the latest US FDA approvals, the week of December 9 -  December 15, 2023Belzutifan (Welireg) for RCCThe FDA has approved belzutifan (Welireg) for patients with advanced…

Continue Reading030 — 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

029 — Iptacopan for PNH, Casgevy and Lyfgenia for Sickle Cell Disease, SGT-003 in Duchenne Muscular Dystrophy, New Fingerstick Blood Collection Device

Here is information on the latest US FDA approvals, the week of December 2 -  December 8, 2023 Iptacopan (Fabhalta) for PNH The FDA has approved iptacopan (Fabhalta) as the first…

Continue Reading029 — Iptacopan for PNH, Casgevy and Lyfgenia for Sickle Cell Disease, SGT-003 in Duchenne Muscular Dystrophy, New Fingerstick Blood Collection Device