Blog
RSS FeedPosted 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 30 Jan 2025
Ironwood Pharmaceuticals initiates apraglutide NDA submission
29 January 2025 - Initiated rolling new drug application submission, now to include long-term extension data given continued clinical improvement over ...
Posted by Michael Wonder on 29 Jan 2025
FDA grants Vicore’s buloxibutid fast track designation for idiopathic pulmonary fibrosis
29 January 2025 - Vicore Pharma today announced that the US FDA has granted fast track designation to its lead ...
Posted by Michael Wonder on 29 Jan 2025
Scholar Rock submits biologics license application to the US FDA for apitegromab as a treatment for patients with spinal muscular atrophy
29 January 2025 - Scholar Rock’s BLA submission is based on the Phase 3 SAPPHIRE trial that demonstrated a statistically significant ...
Posted by Michael Wonder on 29 Jan 2025
Alvotech and Teva announce filing acceptance of US biologics license applications for AVT05, a proposed biosimilar to Simponi and Simponi Aria (golimumab)
27 January 2025 - Alvotech and Teva Pharmaceuticals today announced that the US FDA has accepted for review biologics license applications ...
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
Beckman Coulter receives FDA breakthrough device designation for Alzheimer's disease blood test
28 January 2025 - Beckman Coulter today announced the US FDA has granted breakthrough device designation to Beckman Coulter's Access p‑Tau217/β-Amyloid ...
Posted by Michael Wonder on 28 Jan 2025
Beacon Therapeutics granted FDA regenerative medicine advanced therapy designation for laru-zova (AGTC-501)
28 January 2025 - Recognises preliminary clinical evidence from the Phase 2 DAWN and SKYLINE trials of laru-zova in X-linked retinitis ...
Posted by Michael Wonder on 28 Jan 2025
Saol Therapeutics announces FDA acceptance of new drug application for SL1009 for treatment of pyruvate dehydrogenase complex deficiency
28 January 2025 - Saol Therapeutics announced today that the US FDA has accepted for review the new drug application for ...
Posted by Michael Wonder on 28 Jan 2025
Vanda Pharmaceuticals accepts FDA opportunity for a hearing on new drug application for tradipitant in gastroparesis
27 January 2025 - Highlights faulty FDA review. ...
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 grants priority review to Merck’s application for Welireg (belzutifan) for the treatment of patients with advanced pheochromocytoma and paraganglioma
27 January 2025 - Acceptance based on objective response rate data from the Phase 2 LITESPARK-015 trial evaluating WELIREG in certain ...