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RSS FeedPosted 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 04 Dec 2025
Pre-filled syringe presentation of Byooviz, Samsung Bioepis’ biosimilar to Lucentis (ranibizumab), gains European approval
2 December 2025 - Samsung Bioepis today announced that the EMA’s CHMP has adopted a positive opinion for Byooviz pre-filled syringe, ...
Posted by Michael Wonder on 04 Dec 2025
High risk early breast cancer patients in Quebec left behind by recent INESSS recommendation
3 December 2025 - Quebec has the highest rate of breast cancer in Canada. The Government of Quebec recently endorsed lowering ...
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 28 Nov 2025
Celltrion receives Health Canada approval for Eydenzelt, a biosimilar referencing Eylea (aflibercept 2 mg)
27 November 2025 - The approval is based on the totality of evidence, including analytical, nonclinical, and clinical data from global ...
Posted by Michael Wonder on 27 Nov 2025
MHRA approves inavolisib for the treatment of breast cancer
26 November 2025 - The MHRA has today approved inavolisib (Itovebi) for the treatment of adults with a type of breast ...
Posted by Michael Wonder on 27 Nov 2025
Alvotech announces approval of AVT03, a biosimilar to Prolia and Xgeva (denosumab) in the European Economic Area
November 24, 2025 - Alvotech today announced that the European Commission has approved AVT03 as a biosimilar to Prolia and ...
Posted by Michael Wonder on 26 Nov 2025
Chinese pharma is on the cusp of going global
23 November 2025 - Its fast moving, cut price drugmakers stand to make more money abroad than at home. ...
Posted by Michael Wonder on 26 Nov 2025
Hundreds could benefit from life saving blood cancer treatment recommended by NICE
25 November 2025 - People with a rare and aggressive blood cancer will benefit from a potentially life saving treatment, following ...
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 25 Nov 2025
Dupixent (dupilumab) approved as the first targeted medicine in the European Union in over a decade for chronic spontaneous urticaria
25 November 2025 - Approval based on Phase 3 trials showing Dupixent significantly reduced itch and hives at 24 weeks compared ...
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 24 Nov 2025
Bristol Myers Squibb receives approval from the European Commission to expand use of CAR T cell therapy Breyanzi for relapsed or refractory mantle cell lymphoma
24 November 2025 - In the TRANSCEND MCL trial, 82.7% of patients responded to Breyanzi, with 71.6% of patients achieving complete ...