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RSS FeedPosted by Michael Wonder on 11 Jun 2026
Italfarmaco announces Health Canada acceptance and priority review of new drug submission for givinostat as a Duchenne muscular dystrophy treatment
10 June 2026 - New drug submission is based on Italfarmaco’s Phase 3 EPIDYS trial data demonstrating meaningful treatment benefits ...
Posted by Michael Wonder on 24 May 2026
Gazyva (obinutuzumab) receives positive reimbursement recommendation from Canada's Drug Agency (CDA-AMC) for adults with active lupus nephritis
22 May 2026 - Roche Canada is pleased to share that on 6 May 2026, Canada's Drug Agency recommended Gazyva ...
Posted by Michael Wonder on 24 May 2026
FDA grants accelerated approval to Gilead’s Hepcludex (bulevirtide-gmod), the first and only approved treatment for chronic hepatitis delta virus
22 May 2026 - Approval introduces the first FDA approved therapy for this disease with limited treatment options and high ...
Posted by Michael Wonder on 22 May 2026
Otarmeni (lunsotogene parvec) receives EMA filing acceptance for genetic hearing loss
22 May 2026 - Regeneron Pharmaceuticals today announced the EMA has accepted for review under accelerated assessment the marketing authorisation application ...
Posted by Michael Wonder on 22 May 2026
Camizestrant in combination with a CDK4/6 inhibitor recommended for approval in the EU by CHMP for 1st-line advanced ER-positive breast cancer
22 May 2026 - Recommendation based on SERENA-6 Phase 3 trial results which showed combination reduced the risk of disease progression ...
Posted by Michael Wonder on 22 May 2026
AbbVie announces positive CHMP opinion for Maviret (glecaprevir/pibrentasvir) for the treatment of acute hepatitis C infection
22 May 2026 - The positive opinion is supported by data from the Phase 3 M20-350 study evaluating the safety and ...
Posted by Michael Wonder on 22 May 2026
Enhertu recommended for approval in the EU by CHMP for patients with previously treated HER2-positive metastatic solid tumours
22 May 2026 - Based on three Phase 2 trials of AstraZeneca and Daiichi Sankyo’s Enhertu which showed clinically meaningful responses ...
Posted by Michael Wonder on 22 May 2026
Datroway approved in the US as first TROP2 directed antibody drug conjugate for first-line treatment of patients with metastatic triple negative breast cancer who are not PD-1/PD-L1 inhibitor candidates
22 May 2026 - Daiichi Sankyo and AstraZeneca’s Datroway (datopotamab deruxtecan-dlnk) has been approved in the US for the treatment ...
Posted by Michael Wonder on 22 May 2026
Datroway approved in the US as first TROP2-directed antibody drug conjugate for 1st-line treatment of patients with metastatic triple-negative breast cancer who are not PD-1/PD-L1 inhibitor candidates
22 May 2026 - AstraZeneca and Daiichi Sankyo’s Datroway is the only TROP2-directed antibody drug conjugate to prolong overall survival in ...
Posted by Michael Wonder on 22 May 2026
FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic triple negative breast cancer
22 May 2026 - Today, the FDA approved datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo) for adult patients with unresectable or metastatic ...
Posted by Michael Wonder on 22 May 2026
FDA approves first treatment for chronic hepatitis delta virus infection
22 May 2026 - Today, the US FDA approved Hepcludex (bulevirtide-gmod) injection to treat chronic hepatitis delta virus infection in adults ...
Posted by Michael Wonder on 22 May 2026
More New Zealanders could benefit from funded vaccines from 2027
21 May 2026 - PHARMAC is proposing changes that would give more New Zealanders access to funded vaccines from 2027, ...
Posted by Michael Wonder on 22 May 2026
Vertex announces new drug submission for suzetrigine has been accepted for review by Health Canada for the treatment of moderate to severe acute pain in adults
21 May 2026 - Vertex Pharmaceuticals today announced that Health Canada has accepted for review a new drug submission for ...
Posted by Michael Wonder on 22 May 2026
The EMA accepts Teva’s marketing authorisation application for olanzapine long-acting injectable for the treatment of schizophrenia in adults
21 May 2026 - Teva Pharmaceuticals and Medincell today announced that the EMA has accepted the marketing authorisation application for olanzapine ...
Posted by Michael Wonder on 22 May 2026
FDA approves new Guardant360 Liquid CDx, the largest FDA approved liquid biopsy panel with a 100x expanded footprint
20 May 2026 - Guardant Health today announced that the US FDA has approved Guardant360 Liquid CDx, advancing blood-based comprehensive genomic ...
Posted by Michael Wonder on 22 May 2026
After decade-long climb in Korea, AstraZeneca’s Tagrisso hits access wall
19 May 2026 - AstraZeneca’s Tagrisso has become strong enough in early EGFR mutated lung cancer that Korean doctors say ...