Blog
RSS FeedPosted by Michael Wonder on 05 Feb 2025
FDA approves Roche’s Susvimo as the first and only continuous delivery treatment for the leading cause of diabetes-related blindness
4 February 2025 - Approval marks the second indication for Susvimo in addition to neovascular or ‘wet’ age-related macular degeneration, ...
Posted by Michael Wonder on 03 Feb 2025
Roche receives FDA approval for the first companion diagnostic to identify patients with HER2 ultralow metastatic breast cancer eligible for Enhertu
31 January 2025 - The PATHWAY HER2 (4B5) test, the first and only FDA approved companion diagnostic for assessing HER2 low ...
Posted by Michael Wonder on 02 Feb 2025
US FDA approves Celltrion's Avtozma (tocilizumab-anoh), a biosimilar to Actemra
30 January 2025 - Approval was received for multiple indications, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic ...
Posted by Michael Wonder on 01 Feb 2025
FDA approves novel non-opioid treatment for moderate to severe acute pain
30 January 2025 - First drug approved in new class of non-pioid pain medicines; agency continues to take steps to support ...
Posted by Michael Wonder on 31 Jan 2025
Axsome Therapeutics announces FDA approval of Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults
30 January 2025 - A single oral dose of Symbravo provided rapid migraine pain freedom and return to normal functioning within ...
Posted by Michael Wonder on 30 Jan 2025
Vertex announces FDA approval of Journavx (suzetrigine), a first in class treatment for adults with moderate to severe acute pain
30 January 2025 - Journavx is the first and only approved non-opioid oral pain signal inhibitor and the first new class ...
Posted by Michael Wonder on 29 Jan 2025
FDA approves Ozempic (semaglutide) as the only GLP-1 RA to reduce the risk of worsening kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease
28 January 2025 - The approval is based on the results of the pivotal FLOW Phase 3b kidney outcomes trial and ...
Posted by Michael Wonder on 28 Jan 2025
Enhertu approved in the US as first HER2 directed therapy for patients with HER2 low or HER2 ultralow metastatic breast cancer following disease progression after one or more endocrine therapies
27 January 2025 - Based on DESTINY-Breast06 phase 3 trial results which showed Enhertu demonstrated superiority versus chemotherapy with a ...
Posted by Michael Wonder on 27 Jan 2025
FDA approves Leqembi (lecanemab-irmb) IV maintenance dosing for the treatment of early Alzheimer's disease
26 January 2025 - Once every four weeks maintenance dosing may be easier for patients and care partners to continue ...
Posted by Michael Wonder on 23 Jan 2025
Medexus announces FDA approval of Grapafex (treosulphan) for injection
22 January 2025 - Medexus will target a commercial launch in 1H CY2025; potential for annual product-level revenue to exceed ...
Posted by Michael Wonder on 21 Jan 2025
Spravato (esketamine) approved in the US as the first and only monotherapy for adults with treatment-resistant depression
21 January 2024 - Following US FDA priority review, approval is based on data demonstrating Spravato alone met its primary endpoint ...
Posted by Michael Wonder on 19 Jan 2025
US FDA approves FoundationOne CDx as a companion diagnostic for Ojemda (tovorafenib) to treat the most common form of childhood brain tumour in paediatric patients
17 January 2025 - The approval supports the identification of therapeutic options for patients with relapsed or refractory BRAF altered paediatric ...
Posted by Michael Wonder on 17 Jan 2025
FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic, HR positive, HER2 negative breast cancer
17 January 2025 - Today, the FDA approved datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo), a Trop-2-directed antibody and topoisomerase inhibitor conjugate, ...
Posted by Michael Wonder on 17 Jan 2025
Atara Biotherapeutics provides regulatory and business update on Ebvallo (tabelecleucel)
16 January 2025 - Atara received FDA complete response letter solely related to inspection findings at third party manufacturer. ...
Posted by Michael Wonder on 16 Jan 2025
FDA approves sotorasib with panitumumab for KRAS G12C mutated colorectal cancer
16 January 2025 - Today, the FDA approved sotorasib (Lumakras, Amgen) with panitumumab (Vectibix, Amgen) for adult patients with KRAS ...