neurology

048 — Beqvez for Hemophilia B, Anktiva for Bladder Cancer, Pivya for UTI, Tovorafenib for Pediatric Low-Grade Glioma, Entyvio Maintenance for Crohn’s Disease, Alecensa for NSCLC, SPG601 for Fragile X Syndrome, Lumisight for Visualizing Breast Cancer

Beqvez for Hemophilia BThe FDA has approved fidanacogene elaparvovec-dzkt (Beqvez), a gene therapy, for adults with moderate to severe hemophilia B who meet certain criteria. Beqvez is a one-time treatment…

Continue Reading048 — Beqvez for Hemophilia B, Anktiva for Bladder Cancer, Pivya for UTI, Tovorafenib for Pediatric Low-Grade Glioma, Entyvio Maintenance for Crohn’s Disease, Alecensa for NSCLC, SPG601 for Fragile X Syndrome, Lumisight for Visualizing Breast Cancer

047 — Fasenra Pediatric Asthma Expansion, Xcopri New Delivery Methods, New MRD Endpoint for Myeloma, Mpox PCR Test Home Collection Kit, Dovato for Adolescents With HIV

Here is information on the latest US FDA approvals, the week of April 8 – April 12, 2024visit learnAMAstyle.com Fasenra Pediatric Asthma ExpansionThe FDA has approved benralizumab (Fasenra) for add-on maintenance…

Continue Reading047 — Fasenra Pediatric Asthma Expansion, Xcopri New Delivery Methods, New MRD Endpoint for Myeloma, Mpox PCR Test Home Collection Kit, Dovato for Adolescents With HIV

044 — Nexletol and Nexlizet for LDL Lowering and CV Risk, Iclusig for ALL, Elahere for Ovarian Cancer, Duvyzat for DMD, Spevigo for Psoriasis, Tryvio for Hypertension, Opsynvi for PAH, Lenmeldy for Juvenile Metachromatic Leukodystrophy

Here is information on the latest US FDA approvals, the week of March 18 – March 22, 2024Nexletol and Nexlizet for LDL Lowering and CV Risk, Iclusig for ALL, Elahere…

Continue Reading044 — Nexletol and Nexlizet for LDL Lowering and CV Risk, Iclusig for ALL, Elahere for Ovarian Cancer, Duvyzat for DMD, Spevigo for Psoriasis, Tryvio for Hypertension, Opsynvi for PAH, Lenmeldy for Juvenile Metachromatic Leukodystrophy

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

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

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

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

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

016 — New MS Biosimilar, RSV Maternal Immunization, Rybrevant in Advanced NSCLC, Xtandi in Early PCa

Check out our free downloads:Implementing AMA Style – 8 Things to Get Right in Your Next ProjectNeeds Assessments – 7 Essentials for Getting FundedWorking With Your Medical Writer – 8…

Continue Reading016 — New MS Biosimilar, RSV Maternal Immunization, Rybrevant in Advanced NSCLC, Xtandi in Early PCa