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RSS FeedPosted 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
EMA publishes agenda for 27-30 January 2025 CHMP meeting
27 January 2025 - The EMA has published a draft agenda for this week's CHMP meeting. ...
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 29 Jan 2025
Depemokimab accepted for review by the EMA for use in asthma with type 2 inflammation and CRSwNP
28 January 2025 - If approved, depemokimab will be the first ultra long-acting biologic with 6 month dosing. ...
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
Apellis receives approval of Syfovre (pegcetacoplan) in Australia for geographic atrophy
27 January 2025 - Apellis Pharmaceuticals announced today that the TGA has approved Syfovre (pegcetacoplan) for the every-other-month treatment of adult ...
Posted by Michael Wonder on 28 Jan 2025
GSK’s Shingrix new pre-filled syringe presentation accepted for review by EMA
27 January 2025 - If approved, the new presentation will offer a convenient administration option to healthcare professionals. ...
Posted by Michael Wonder on 28 Jan 2025
ImmunityBio announces EMA acceptance of marketing authorisation application for Anktiva for the treatment of patients with BCG unresponsive non-muscle invasive bladder cancer carcinoma in situ
27 January 2025 - Submission is based on the on-going QUILT 3.032 study in which 100 patients with Bacillus Calmette-Guérin (BCG)-unresponsive ...
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 ...