046 — Cilta-cel for Myeloma, Enhertu for HER2-positive Solid Tumors, Fanapt for Bipolar, Zevtera for Multiple Bacterial Infections, TriClip for Tricuspid Regurgitation, Revumenib for Acute Leukemia

Here is information on the latest US FDA approvals, the week of April 1 – April 5, 2024Cilta-cel for MyelomaThe FDA has approved ciltacabtagene autoleucel (Carvykti; cilta-cel) for the treatment…

Continue Reading046 — Cilta-cel for Myeloma, Enhertu for HER2-positive Solid Tumors, Fanapt for Bipolar, Zevtera for Multiple Bacterial Infections, TriClip for Tricuspid Regurgitation, Revumenib for Acute Leukemia

042 — OTC Glucose Monitor, Semaglutide and CVD risk, Juvederm Additional Indication, Nivolumab in mUC, Zanubrutinib in FL, Donanemab and Alzheimer’s, Tocilizumab Biosimilar, Denosumab Biosimilars, Clobetasol Propionate Eye Drops

OTC Glucose MonitorThe FDA has cleared Dexcom Stelo Glucose Biosensor System for over-the-counter (OTC) sale, a first in the agency's history for a continuous glucose monitor (CGM). This clearance follows…

Continue Reading042 — OTC Glucose Monitor, Semaglutide and CVD risk, Juvederm Additional Indication, Nivolumab in mUC, Zanubrutinib in FL, Donanemab and Alzheimer’s, Tocilizumab Biosimilar, Denosumab Biosimilars, Clobetasol Propionate Eye Drops

041 — Amivantamab for NSCLC, Drug-Coated Balloon for ISR, Ibrutinib Oral Suspension, Epcoritamab for Follicular Lymphoma, Govorestat for Galactosemia, Obeticholic Acid for PBC, Biktarvy for HIV, Roluperidone for Schizophrenia

Here is information on the latest US FDA approvals, the week of February 26 – March 1, 2024Amivantamab for NSCLCThe FDA has approved amivantamab (Rybrevant) in combination with chemotherapy (carboplatin-pemetrexed)…

Continue Reading041 — Amivantamab for NSCLC, Drug-Coated Balloon for ISR, Ibrutinib Oral Suspension, Epcoritamab for Follicular Lymphoma, Govorestat for Galactosemia, Obeticholic Acid for PBC, Biktarvy for HIV, Roluperidone for Schizophrenia

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

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

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…

Continue Reading031 — 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

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

028 — Nirogacestat For Desmoid Tumors, Pirtobrutinib for CLL/SLL, Enfortumab Vedotin With Pembrolizumab for UC, Lisocabtagene Maraleucel for CLL/SLL, Xanomeline-trospium for Schizophrenia, Roflumilast for AD

Here is information on the latest US FDA approvals, the week of November 20 -  December 1, 2023Nirogacestat (Ogsiveo) For Desmoid TumorsThe FDA has approved nirogacestat (Ogsiveo) tablets for adult…

Continue Reading028 — Nirogacestat For Desmoid Tumors, Pirtobrutinib for CLL/SLL, Enfortumab Vedotin With Pembrolizumab for UC, Lisocabtagene Maraleucel for CLL/SLL, Xanomeline-trospium for Schizophrenia, Roflumilast for AD

020 — Ryzumvi Mydriasis Reversal Drops, Exxua for MDD, Likmez Metronidazole Liquid Formulation, DNA Test for Hereditary Cancers, Tofidence Actemra Biosimilar, Pompe Disease Combination Therapy, Subcutaneous Entyvio, NurOwn in ALS

Here is information on the latest US FDA approvals, the week of September 25 –  September 29, 2023Ryzumvi (Phentolamine Ophthalmic Solution) for Dilated PupilsThe FDA has approved Ryzumvi (phentolamine ophthalmic…

Continue Reading020 — Ryzumvi Mydriasis Reversal Drops, Exxua for MDD, Likmez Metronidazole Liquid Formulation, DNA Test for Hereditary Cancers, Tofidence Actemra Biosimilar, Pompe Disease Combination Therapy, Subcutaneous Entyvio, NurOwn in ALS

017 — Ilaris for Gout, Generics for ADHD, Balversa for Urothelial Cancer, INO-3107 for Recurrent Respiratory Papillomatosis, Crovalimab for PNH

Check out our free downloads: Implementing AMA Style – 8 Things to Get Right in Your Next Project Needs Assessments – 7 Essentials for Getting Funded Working With Your Medical…

Continue Reading017 — Ilaris for Gout, Generics for ADHD, Balversa for Urothelial Cancer, INO-3107 for Recurrent Respiratory Papillomatosis, Crovalimab for PNH