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RSS FeedPosted 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
Bayer’s Lynkuet (elinzanetant) approved in the US for treatment of moderate to severe vasomotor symptoms due to menopause
24 October 2025 - This approval is supported by data from the Phase 3 OASIS clinical program evaluating Lynkuet (elinzanetant) for ...
Posted by Michael Wonder on 24 Oct 2025
FDA approves revumenib for relapsed or refractory acute myeloid leukaemia with a susceptible NPM1 mutation
24 October 2025 - Today, the FDA approved revumenib (Revuforj, Syndax Pharmaceuticals), a menin inhibitor, for relapsed or refractory acute ...
Posted by Michael Wonder on 24 Oct 2025
Sydnexis receives complete response letter from FDA for SYD-101 to slow paediatric myopia progression
23 October 2025 - Sydnexis, today announced that the US FDA has issued a complete response letter for the new ...
Posted by Michael Wonder on 24 Oct 2025
Biocon Biologics receives Health Canada spproval for Yesintek and Yesintek I.V. (ustekinumab), a biosimilar to Stelara
23 October 2025 - Biocon Biologics today announced that Health Canada has granted a notice of compliance for Yesintek (ustekinumab ...
Posted by Michael Wonder on 24 Oct 2025
Apotex receives Health Canada approval for Loqtorzi - the first and only immuno-therapy for recurrent unresectable or metastatic nasopharyngeal cancer
23 October 2025 - Apotex today announced that Health Canada has granted a notice of compliance for Loqtorzi (toripalimab) for ...
Posted by Michael Wonder on 23 Oct 2025
FDA approves belantamab mafodotin-blmf for relapsed or refractory multiple myeloma
23 October 2025 - Today, the FDA approved belantamab mafodotin-blmf (Blenrep, GlaxoSmithKline), a B-cell maturation antigen (BCMA)-directed antibody and microtubule ...
Posted by Michael Wonder on 23 Oct 2025
Dupixent (dupilumab injection) approved in Canada for adults with inadequately controlled chronic obstructive pulmonary disease
22 October 2025 - Health Canada has approved Dupixent (dupilumab injection) as an add-on maintenance treatment in adult patients with chronic ...
Posted by Michael Wonder on 22 Oct 2025
Tezspire approved in the EU for chronic rhinosinusitis with nasal polyps
22 October 2025 - Approval based on WAYPOINT Phase 3 results demonstrating reduced nasal polyp severity and nasal congestion, near ...
Posted by Michael Wonder on 22 Oct 2025
Lyvdelzi (seladelpar) receives Health Canada approval for the treatment of primary biliary cholangitis
21 October 2025 - Gilead Sciences today announced that Health Canada has approved Lyvdelzi (seladelpar) for the treatment of primary biliary ...
Posted by Michael Wonder on 22 Oct 2025
Pfizer Canada announces Health Canada approval of Abrysvo for adults 18+
21 October 2025 - With the approval of Arbysvo for adults aged 18+, there is now a way to help ...