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RSS FeedPosted by Michael Wonder on 12 Dec 2025
FDA approves niraparib and abiraterone acetate plus prednisone for BRCA2-mutated metastatic castration-sensitive prostate cancer
12 December 2025 - Today, the FDA approved niraparib and abiraterone acetate (Akeega, Janssen Biotech) with prednisone for adults with ...
Posted by Michael Wonder on 12 Dec 2025
FDA approves Uplinza for adults with generalised myasthenia gravis
11 December 2025 - Amgen today announced that the US FDA has approved Uplinza (inebilizumab-cdon) for the treatment of generalised myasthenia ...
Posted by Michael Wonder on 10 Dec 2025
FDA approves first gene therapy treatment for Wiskott-Aldrich syndrome
9 December 2025 - Agency exercises regulatory flexibility to address unmet need for rare, life-threatening disease. ...
Posted by Michael Wonder on 10 Dec 2025
First approval in Commissioner's National Priority Voucher Pilot Program strengthens domestic antibiotic manufacturing capacity
9 December 2025 - The US FDA today approved Augmentin XR (amoxicillin-clavulanate potassium) under the Commissioner's National Priority Voucher pilot program, ...
Posted by Michael Wonder on 07 Dec 2025
FDA approves Omisirge as first approved cell therapy to treat severe aplastic anaemia
5 December 2025 - Ayrmid announces that it has received US FDA approval for Omisirge (Omidubicel-onlv) for the treatment of ...
Posted by Michael Wonder on 05 Dec 2025
Celltrion announces US FDA approval of 300 mg strength of Omyclo (omalizumab-igec), the first and only FDA approved interchangeable biosimilar to Xolair
1 December 2025 - Celltrion today announced the US FDA has approved a new presentation of Omyclo (omalizumab-igec), the first and ...
Posted by Michael Wonder on 04 Dec 2025
FDA approves lisocabtagene maraleucel for relapsed or refractory marginal zone lymphoma
4 December 2025 - Today, the FDA approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, a BMS Company) for adults with relapsed ...
Posted by Michael Wonder on 04 Dec 2025
FDA approves IsoPSA - Cleveland Diagnostics’ novel blood based prostate cancer test
1 December 2025 - Cleveland Diagnostics announced today that the US FDA has approved the company’s IsoPSA in vitro diagnostic ...
Posted by Michael Wonder on 03 Dec 2025
FDA grants traditional approval to pirtobrutinib for chronic lymphocytic leukaemia and small lymphocytic lymphoma
3 December 2025 - Today, the FDA granted traditional approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) for adults with ...
Posted by Michael Wonder on 26 Nov 2025
FDA approves a new treatment for primary immunoglobulin A nephropathy
25 November 2025 - The US FDA has granted accelerated approval to Voyxact (sibeprenlimab-szsi) injection to reduce proteinuria in adults ...
Posted by Michael Wonder on 25 Nov 2025
FDA approves durvalumab for resectable gastric or gastro-oesophageal junction adenocarcinoma
25 November 2025 - Today, the FDA approved durvalumab (Imfinzi, AstraZeneca) with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) chemotherapy as ...
Posted by Michael Wonder on 24 Nov 2025
Novartis receives FDA approval for Itvisma, the only gene replacement therapy for children two years and older, teens, and adults with spinal muscular atrophy
24 November 2024 - Novartis today announced that the US FDA has approved Itvisma (onasemnogene abeparvovec-brve) for the treatment of children ...
Posted by Michael Wonder on 21 Nov 2025
FDA approves pembrolizumab with enfortumab vedotin-ejfv for muscle invasive bladder cancer
21 November 2025 - Today, the FDA approved pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) with ...
Posted by Michael Wonder on 19 Nov 2025
Eylea HD (aflibercept) injection 8 mg approved by FDA for the treatment of macular oedema following retinal vein occlusion and for monthly dosing across approved indications
19 November 2025 - Regeneron Pharmaceuticals today announced that the US FDA has approved Eylea HD (aflibercept) injection 8 mg for ...
Posted by Michael Wonder on 19 Nov 2025
FDA grants traditional approval to tarlatamab-dlle for extensive stage small cell lung cancer
19 November 2025 - Today, the FDA granted traditional approval to tarlatamab-dlle (Imdelltra, Amgen Inc.) for adults with extensive stage ...