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RSS FeedPosted by Michael Wonder on 22 Oct 2025
GondolaBio receives US FDA orphan drug and fast track designations for PORT-77 for the treatment of erythropoietic protoporphyria and X-linked protoporphyria
21 October 2025 - PORT-77 is currently being investigated in the Phase 2A proof of concept trial, GATEWAY, with the primary ...
Posted by Michael Wonder on 22 Oct 2025
Immusoft receives FDA fast track designation for ISP-001, a first in class engineered B-cell therapy for MPS I
21 October 2025 - Prospectively designed for scalability and re-dosability, Immusoft's engineered B cells represent the next generation of advanced ...
Posted by Michael Wonder on 21 Oct 2025
Glaukos announces FDA approval of Epioxa
20 October 2025 - Epioxa expected to be commercially available in Q1, 2026. ...
Posted by Michael Wonder on 21 Oct 2025
Replimune announces FDA acceptance of BLA resubmission of RP1 for the treatment of advanced melanoma
20 October 2025 - Replimune today announced that the US FDA has accepted the resubmission of the biologics license application for ...
Posted by Michael Wonder on 21 Oct 2025
FDA awards first ever national priority vouchers to nine sponsors
16 October 2025 - The US FDA today announced nine voucher recipients under the new Commissioner’s National Priority Voucher (CNPV) pilot ...
Posted by Michael Wonder on 20 Oct 2025
Fast track granted by FDA for NNZ-2591 in Phelan-McDermid syndrome
20 October 2025 - Neuren Pharmaceuticals today announced that the US FDA has granted fast track designation for NNZ-2591 for ...
Posted by Michael Wonder on 20 Oct 2025
Cogent Biosciences announces FDA breakthrough therapy designation for bezuclastinib
20 October 2025 - Detailed results from bezuclastinib’s positive SUMMIT trial evaluating bezuclastinib in patients with non-advanced systemic mastocytosis planned for ...
Posted by Michael Wonder on 20 Oct 2025
FDA approves Roche’s Gazyva/Gazyvaro for the treatment of lupus nephritis
20 October 2025 - FDA approval based on superiority of Gazyva/Gazyvaro over standard therapy alone, as shown in Phase 2 NOBILITY ...
Posted by Michael Wonder on 20 Oct 2025
Xbrane provides regulatory update on FDA review of its ranibizumab biosimilar candidate
19 October 2025 - Xbrane Biopharma announce that the US FDA has issued a complete response letter to the Company’s biologics ...
Posted by Michael Wonder on 19 Oct 2025
Artiva Biotherapeutics announces refractory rheumatoid arthritis as lead indication
16 October 2025 - Artiva Biotherapeutics announced today that the US FDA has granted fast track designation to AlloNK (also ...
Posted by Michael Wonder on 19 Oct 2025
Enterome receives FDA fast track designation in follicular lymphoma for lead OncoMimics immunotherapy EO2463
16 October 2025 - Enterome announces today that the US FDA has granted fast track designation for follicular lymphoma in the ...
Posted by Michael Wonder on 19 Oct 2025
Azurity Pharmaceuticals announces the FDA approval of Ferabright (ferumoxytol injection), the first and only iron-based contrast agent indicated for magnetic resonance imaging of the brain
17 October 2025 - Azurity Pharmaceuticals announced today that the US FDA has approved Ferabright (ferumoxytol injection), the first and only ...
Posted by Michael Wonder on 18 Oct 2025
FDA approves Novo Nordisk's oral semaglutide for cardiovascular risk reduction in adults with type 2 diabetes who are at high risk, including those who have not had a prior CV event
17 October 2025 - In the SOUL trial, oral semaglutide 14 mg reduced the risk of MACE by 14% compared to ...
Posted by Michael Wonder on 17 Oct 2025
Silver Creek Pharmaceuticals receives FDA fast track designation for Scp776 in acute ischaemic stroke
17 October 2025 - Silver Creek Pharmaceuticals today announced that the US FDA has granted fast track designation to scp776, its ...
Posted by Michael Wonder on 17 Oct 2025
Tezspire approved in the US for chronic rhinosinusitis with nasal polyps
17 October 2025 - AstraZeneca and Amgen’s Tezspire (tezepelumab) has been approved in the US for the add-on maintenance treatment of ...