050 — mRNA Anti-EBV Cancer Vaccine, BTX-9341 for Breast Cancer, Nivolumab Hyaluronidase Formulation, ColoSense CRC Screening Test

mRNA Anti-EBV Cancer VaccineA novel mRNA therapeutic cancer vaccine, WGc-043, has received approval for an  investigational new drug (IND) application, allowing it to be used in clinical trials for patients…

Continue Reading050 — mRNA Anti-EBV Cancer Vaccine, BTX-9341 for Breast Cancer, Nivolumab Hyaluronidase Formulation, ColoSense CRC Screening Test

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

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

027 — Capivasertib for Breast Cancer, Repotrectinib for NSCLC, Enzalutamide for Prostate Cancer, Pembrolizumab for Stomach Cancer, Hypertension Device

Here is information on the latest US FDA approvals, the week of November 13 -  November 17, 2023 Capivasertib (Truqap) for Breast CancerThe FDA has approved capivasertib (Truqap) in combination…

Continue Reading027 — Capivasertib for Breast Cancer, Repotrectinib for NSCLC, Enzalutamide for Prostate Cancer, Pembrolizumab for Stomach Cancer, Hypertension Device

007 — Talzenna, Elevidys, Jardiance, Litfulo, Blincyto, Vyvgart Hytrulo, Ultravist

Here is information on the latest US FDA approvals, the week of June 19 –  June 23, 2023. Please subscribe, rate and review this podcast. Thank you!Talzenna® plus Xtandi® for…

Continue Reading007 — Talzenna, Elevidys, Jardiance, Litfulo, Blincyto, Vyvgart Hytrulo, Ultravist