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

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

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

024 — Loqtorzi, Vabysmo, Omvoh, Vamorolone, Tibsovo, FluMist

Here is information on the latest US FDA approvals, the week of October  23 -  October 27, 2023 Loqtorzi (toripalimab-tpzi) for Nasopharyngeal Carcinoma The FDA has approved Loqtorzi (toripalimab-tpzi), a…

Continue Reading024 — Loqtorzi, Vabysmo, Omvoh, Vamorolone, Tibsovo, FluMist

023 — Bimzelx (bimekizumab); Keytruda (Pembrolizumab); Opdivo (nivolumab); Zilbrysq (zilucoplan); Cabtreo (IDP-126); Penbraya; Voxzogo (vosoritide); Qlosi (pilocarpine); Maxigesic IV (paracetomol/ibuprofen); Xphozah (tenapanor); Zymfentra (SC infliximab biosimilar)

Here is information on the latest US FDA approvals, the week of October  16 -  October 20, 2023 Bimzelx (bimekizumab) for Moderate-to-Severe Plaque Psoriasis The FDA has approved BIMZELX® (bimekizumab-bkzx)…

Continue Reading023 — Bimzelx (bimekizumab); Keytruda (Pembrolizumab); Opdivo (nivolumab); Zilbrysq (zilucoplan); Cabtreo (IDP-126); Penbraya; Voxzogo (vosoritide); Qlosi (pilocarpine); Maxigesic IV (paracetomol/ibuprofen); Xphozah (tenapanor); Zymfentra (SC infliximab biosimilar)

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

015 — Myeloma Bispecific, Uveal Melanoma, HD Eylea, Huntington’s, Fibrodysplasia Ossificans Progressive, CHAPLE Disease

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

Continue Reading015 — Myeloma Bispecific, Uveal Melanoma, HD Eylea, Huntington’s, Fibrodysplasia Ossificans Progressive, CHAPLE Disease