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RSS FeedPosted by Michael Wonder on 06 Nov 2025
FDA approves daratumumab and hyaluronidase-fihj for high-risk smoldering multiple myeloma
6 November 2025 - On November 6, 2025, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech) ...
Posted by Michael Wonder on 06 Nov 2025
argenx announces Vvygart SC pre-filled syringe for self-Injection in chronic inflammatory demyelinating polyneuropathy authorised for sale by Health Canada
5 November 2025 - argenx today announced that Health Canada has issued a Notice of Compliance authorising Vvyvart SC (efgartigimod alfa ...
Posted by Michael Wonder on 05 Nov 2025
FDA issues complete response letter for Biohaven's Vyglyxia (troriluzole) new drug application for spinocerebellar ataxia
4 November 2025 - Biohaven today announced that it has received a complete response letter from the US FDA for the ...
Posted by Michael Wonder on 04 Nov 2025
US FDA grants interchangeability designation to Celltrion's denosumab biosimilars, Stoboclo (denosumab-bmwo) and Ozenvelt (denosumab-bmwo)
30 October 2025 - The US FDA approved Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo) as interchangeable with the reference products Prolia (denosumab) ...
Posted by Michael Wonder on 03 Nov 2025
US FDA approves Kygevvi (doxecitine and doxribtimine), the first and only treatment for adults and children living with thymidine kinase 2 deficiency
3 November 2025 - UCB today announced that Kygevvi has been granted approval by the US FDA for the treatment ...
Posted by Michael Wonder on 03 Nov 2025
Alvotech provides update on the status of US biologics license application for AVT05
2 November 2025 - Alvotech announced today that the US FDA has issued a complete response letter for Alvotech’s biologics ...
Posted by Michael Wonder on 01 Nov 2025
Elahere receives positive reimbursement recommendation by Canada's Drug Agency for certain types of platinum-resistant ovarian cancers
30 October 2025 - Elahere was submitted for reimbursement review 180 days prior to Health Canada's approval in line with ...
Posted by Michael Wonder on 31 Oct 2025
Enhertu approved in Canada as the first and only HER2 directed therapy for patients with HR positive HER2 low or HER2 ultra low metastatic breast cancer, following disease progression after one or more endocrine therapies
29 October 2025 - Based on the DESTINY-Breast06 Phase 3 trial results demonstrating statistically significant and clinically meaningful progression-free survival ...
Posted by Michael Wonder on 31 Oct 2025
NICE’s backing of the prostate cancer drug abiraterone could help thousands and save the NHS millions
30 October 2025 - Today we’ve published final draft guidance recommending abiraterone and its generic variants in combination with androgen ...
Posted by Michael Wonder on 28 Oct 2025
Koselugo approved in the EU for plexiform neurofibromas in adults with neurofibromatosis type 1
28 August 2025 - Approval based on KOMET Phase 3 trial results which showed 20% objective response rate in tumour ...
Posted by Michael Wonder on 27 Oct 2025
US FDA approves updated indication for Winrevair (sotatercept-csrk) in adults with pulmonary arterial hypertension (WHO Group 1 pulmonary hypertension) based on Phase 3 ZENITH study
27 October 2025 - Merck today announced that the US FDA has approved an update to the US product label based ...
Posted by Michael Wonder on 27 Oct 2025
Lilly's Omvoh (mirikizumab-mrkz) approved by US FDA as a single-injection maintenance regimen in adults with ulcerative colitis
27 October 2025 - Omvoh now offers patients a simplified maintenance experience with one monthly injection, replacing the previous two injection ...
Posted by Michael Wonder on 27 Oct 2025
Health Canada grants authorisation for Leqembi (lecanemab) for the treatment of early Alzheimer’s disease
26 October 2025 - Eisai and Biogen announced today that Health Canada has issued a notice of compliance with conditions for ...
Posted by Michael Wonder on 25 Oct 2025
Receipt of complete response ketter from US FDA for investigational ND0612
23 October 2025 - Mitsubishi Tanabe Pharma today announced that the US FDA has issued a complete response letter for ...
Posted by Michael Wonder on 24 Oct 2025
Up to 6,000 patients to benefit from NICE-approved life-extending prostate cancer drug
24 October 2025 - People living with metastatic prostate cancer in England will gain access to a new treatment combination from ...