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RSS FeedPosted by Michael Wonder on 23 Oct 2025
FDA approves belantamab mafodotin-blmf for relapsed or refractory multiple myeloma
23 October 2025 - Today, the FDA approved belantamab mafodotin-blmf (Blenrep, GlaxoSmithKline), a B-cell maturation antigen (BCMA)-directed antibody and microtubule ...
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 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
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
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 ...
Posted by Michael Wonder on 15 Oct 2025
Roche's Elecsys pTau181 becomes the only FDA cleared blood test for use in primary care to rule out Alzheimer's related amyloid pathology
13 October 2025 - Roche today announced that the US FDA has cleared its Elecsys pTau181 test, the only blood ...
Posted by Michael Wonder on 13 Oct 2025
US FDA approves updated indication statement for Rinvoq (upadacitinib) for the treatment of inflammatory bowel disease
13 October 2025 - Updated indication allows the use of Rinvoq (upadacitinib) prior to the use of tumour necrosis factor blocking ...
Posted by Michael Wonder on 11 Oct 2025
SQ Innovation announces FDA approval of Lasix ONYU for treatment of edema in heart failure
8 October 2025 - -- SQ Innovation today announced that the US FDA has approved its drug-device combination Lasix ONYU ...
Posted by Michael Wonder on 10 Oct 2025
FDA approves expanded indication for Uzedy (risperidone) extended release injectable suspension as a treatment for adults living with bipolar I disorder
10 October 2025 - Teva Pharmaceuticals announced today that the US FDA has approved Uzedy (risperidone) as a once-monthly extended-release injectable ...
Posted by Michael Wonder on 10 Oct 2025
Celltrion receives US FDA approval for Eydenzelt (aflibercept-boav), biosimilar referencing Eylea (aflibercept)
9 October 2025 - Celltrion today announced that the US FDA has approved Eydenzelt (aflibercept-boav), biosimilar referencing Eylea (aflibercept), for the ...
Posted by Michael Wonder on 10 Oct 2025
US FDA approves Boehringer’s Jascayd (nerandomilast tablets) as first new treatment option for adults with IPF in over a decade
9 October 2025 - Approval is based on results from two clinical trials, which showed reduction in forced vital capacity decline ...
Posted by Michael Wonder on 09 Oct 2025
Richter and Hikma receive FDA approval for denosumab biosimilars Enoby and Xtrenbo, referencing Prolia and Xgeva
29 September 2025 - Gedeon Richter and Hikma Pharmaceuticals announce today that the US FDA has granted approval for the ...
Posted by Michael Wonder on 08 Oct 2025
Xspray Pharma provides update on the FDA process for Dasynoc – observations at contract manufacturer delay approval
8 October 2025 - Xspray Pharma has received a complete response letter from the US FDA concerning the Company’s new ...