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RSS FeedPosted by Michael Wonder on 03 Jun 2025
FDA approves darolutamide for metastatic castration-sensitive prostate cancer
3 June 2025 - Today, the FDA approved darolutamide (Nubeqa) for metastatic castration-sensitive prostate cancer (mCSPC). ...
Posted by Michael Wonder on 02 Jun 2025
RSV prophylaxis with nirsevimab: benefits for healthy children in the first RSV season
2 June 2025 - Children immunised with the antibody nirsevimab are significantly less likely to develop RSV-related lower respiratory tract infections. ...
Posted by Michael Wonder on 02 Jun 2025
Garadacimab in hereditary angioedema: evidence of considerable additional benefit
2 June 2025 - An indirect comparison shows a significant reduction in the monthly rate of attacks and other benefits. ...
Posted by Michael Wonder on 02 Jun 2025
Enhertu (trastuzumab deruxtecan) receives time limited reimbursement recommendation from Canada's Drug Agency for gastric cancer
23 May 2025 - AstraZeneca and Daiichi Sankyo are pleased to announce that Canada's Drug Agency has issued a time-limited reimbursement ...
Posted by Michael Wonder on 01 Jun 2025
Moderna receives US FDA approval for COVID-19 vaccine mNEXSPIKE
31 May 2025 - mNEXSPIKE becomes Moderna's third FDA approved product. ...
Posted by Michael Wonder on 29 May 2025
Eton Pharmaceuticals announces US FDA approval for Khindivi (hydrocortisone) oral solution
28 May 2025 - Commercial launch expected the week of 2 June 2025. ...
Posted by Michael Wonder on 29 May 2025
Alcon announces FDA approval of Tryptyr (acoltremon ophthalmic solution) 0.003% for the treatment of the signs and symptoms of dry eye disease
28 May 2025 - Tryptyr is a first in class TRPM8 receptor agonist that rapidly stimulates natural tear production in patients ...
Posted by Michael Wonder on 28 May 2025
Bristol Myers Squibb receives European Commission approval for the subcutaneous formulation of Opdivo (nivolumab) across multiple solid tumour indications
28 May 2025 - Approval is based on results from the Phase 3 CheckMate -67T clinical trial which demonstrated non-inferiority in ...
Posted by Michael Wonder on 28 May 2025
New subcutaneous formulation of Opdivo approved in Canada for use across all authorised solid tumour indications
27 May 2025 - Subcutaneous option of established immunotherapy offers potential to reduce time in clinic and ease infusion burden. ...
Posted by Michael Wonder on 27 May 2025
BeiGene receives positive CHMP opinion for Tevimbra as a first-line treatment for nasopharyngeal cancer
27 May 2025 - Positive opinion for Tevimbra in combination with chemotherapy as a first-line treatment of nasopharyngeal cancer based ...
Posted by Michael Wonder on 27 May 2025
Imfinzi recommended for approval in the EU by CHMP as first and only peri-operative immunotherapy for muscle-invasive bladder cancer
27 May 2025 - Recommendation based on NIAGARA Phase III trial results which showed a 32% reduction in the risk of ...
Posted by Michael Wonder on 27 May 2025
Arcutis’ Zoryve (roflumilast) 0.3% topical foam approved by US FDA for the treatment of plaque psoriasis in adults and adolescents ages 12 and older
22 May 2025 - Fifth FDA approval for Zoryve in less than three years. ...
Posted by Michael Wonder on 27 May 2025
Eylea 8 mg with extended 6 month treatment interval recommended for approval in EU
23 May 2025 - CHMP opinion is based on the findings from the pivotal clinical trials PULSAR in neovascular (wet) ...
Posted by Michael Wonder on 25 May 2025
Blenrep (belantamab mafodotin) combinations receive positive CHMP opinion in relapsed/refractory multiple myeloma
23 May 2025 - Positive opinion supported by superior efficacy shown in two head-to-head Phase 3 trials, including overall survival in ...
Posted by Michael Wonder on 25 May 2025
SpringWorks Therapeutics receives positive CHMP opinion for mirdametinib for the treatment of adult and paediatric patients with NF1-PN
23 May 2025 - If approved, mirdametinib is expected to be the first and only therapy in the European Union with ...