infectious disease

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

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

045 — Winrevair for PAH, Vafseo for CKD, Ultomiris for NMOSD, Evolut FX+ for TAVR, Vemlidy for Pediatric HBV, Pemgarda for COVID

Here is information on the latest US FDA approvals, the week of March 25 – March 29, 2024Winrevair for PAHThe FDA has approved sotatercept-csrk (Winrevair) for the treatment of adults…

Continue Reading045 — Winrevair for PAH, Vafseo for CKD, Ultomiris for NMOSD, Evolut FX+ for TAVR, Vemlidy for Pediatric HBV, Pemgarda for COVID

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

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

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

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

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