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RSS FeedPosted by Michael Wonder on 09 Jun 2025
SMC - June 2025 decisions
9 June 2025 - The SMC, which advises on newly licensed medicines for use by NHSScotland, has today published advice ...
Posted by Michael Wonder on 07 Jun 2025
European Commission approves Duvyzat for the treatment of Duchenne muscular dystrophy
6 June 2025 - The approval is based on Phase 3 EPIDYS trial data that demonstrated meaningful treatment benefits in ambulant ...
Posted by Michael Wonder on 06 Jun 2025
Fixed-duration Calquence-based regimens approved in EU for patients with chronic lymphocytic leukaemia in the first-line setting
6 June 2025 - AMPLIFY Phase III trial results demonstrated statistically significant and clinically meaningful improvement in progression-free survival for ...
Posted by Michael Wonder on 06 Jun 2025
Merz Aesthetics receives approval from Health Canada for Radiesse as an aesthetic injectable for the treatment of moderate wrinkles in the décolleté area
5 June 2025 - Merz Aesthetics Canada announced today the Health Canada approval for Radiesse for the treatment of moderate ...
Posted by Michael Wonder on 06 Jun 2025
Biogen disappointed by INESSS recommendation on Skyclarys and its impact on Quebec patients with Friedreich ataxia
5 June 2025 - Biogen Canada is disappointed by INESSS's recommendation against listing Skyclarys (omaveloxolone), despite its therapeutic potential for ...
Posted by Michael Wonder on 06 Jun 2025
Sydnexis announces European Commission approval of SYD-101, the first and only pharmaceutical treatment for slowing the progression of paediatric myopia
5 June 2025 - Exclusive licensing partner Santen will commercialise SYD-101 under the brand name Ryjunea in the EU. ...
Posted by Michael Wonder on 05 Jun 2025
TGA approves weight loss drug to treat sleep disorder
4 June 2025 - The country’s medicines regulator has approved the use of a GLP-1 weight-loss drug to treat people ...
Posted by Michael Wonder on 05 Jun 2025
Roche’s Evrysdi tablet approved by European Commission as first and only for spinal muscular atrophy
4 June 2025 - Simplified storage and administration of new tablet formulation may provide greater freedom and independence for people with ...
Posted by Michael Wonder on 04 Jun 2025
MHRA approves aumolertinib to treat non-small cell lung cancer
3 June 2025 - The MHRA has approved aumolertinib (Aumseqa) for adult patients with non-small cell lung cancer. ...
Posted by Michael Wonder on 03 Jun 2025
European Commission approves Adcetris (brentuximab vedotin) for the treatment of adult patients with newly diagnosed stage IIb/III/IV Hodgkin lymphoma in combination with ECADD
3 June 2025 - Approval based on positive results from the Phase 3 HD21 trial for stage IIb with risk factors/III/IV ...
Posted 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. ...