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RSS FeedPosted by Michael Wonder on 10 Jul 2024
Outlook Therapeutics announces UK MHRA marketing authorisation of Lytenava (bevacizumab gamma) for the treatment of wet AMD
8 July 2024 - Initial commercial launches of Lytenava (bevacizumab gamma) in the EU and UK anticipated in calendar Q1, 2025. ...
Posted by Michael Wonder on 10 Jul 2024
NICE recommends Ebglyss (lebrikizumab) for use in moderate to severe atopic dermatitis in the NHS England in eligible adolescents and adults
10 July 2024 - Following approval of the European Commission (October 2023) and the MHRA (December 2023), lebrikizumab will be available ...
Posted by Michael Wonder on 10 Jul 2024
Mirum Pharmaceuticals’ Livmarli approved in the European Union for patients with progressive familial intrahepatic cholestasis
8 July 2024 - Mirum Pharmaceuticals today announced that the European Commission has granted marketing authorization for Livmarli (maralixibat) oral solution ...
Posted by Michael Wonder on 10 Jul 2024
Lisocabtagene maraleucel for the treatment of adults with relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma
10 July 2024 - NICE is unable to make a recommendation about the use in the NHS of lisocabtagene maraleucel (Breyanzi) ...
Posted by Michael Wonder on 09 Jul 2024
FDA approves Arcutis’ Zorvye (roflumilast) cream 0.15% for the treatment of atopic dermatitis in adults and children down to 6 years of age
9 July 2024 - Commercial product expected to be available by the end of July. ...
Posted by Michael Wonder on 08 Jul 2024
Xpovio (selinexor) approved for new indication in DLBCL in China, bringing a new treatment option to patients in the country
5 July 2024 - Results from the registrational SEARCH study in China showed that the overall response rate among the ...
Posted by Michael Wonder on 07 Jul 2024
FDA approves Genentech’s Vabysmo pre-filled syringe for three leading causes of vision loss
4 July 2024 - Vabysmo PFS is the first and only syringe pre-filled with an FDA approved bi-specific antibody to treat ...
Posted by Michael Wonder on 05 Jul 2024
Tagrisso with the addition of chemotherapy approved in the EU as new first-line treatment for patients with EGFR-mutated advanced lung cancer
5 July 2024 - Approval based on FLAURA2 results which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly ...
Posted by Michael Wonder on 04 Jul 2024
Gyre Therapeutics announces China’s NMPA approval of avatrombopag maleate tablets for the treatment of CLD associated thrombocytopenia
2 July 2024 - Gyre Therapeutics today announced that China’s National Medical Products Administration has approved Gyre Pharmaceuticals’ avatrombopag maleate tablets ...
Posted by Michael Wonder on 04 Jul 2024
Health Canada authorises Rybrevant (amivantamab) in combination with carboplatin and pemetrexed as the only targeted first-line treatment approved for patients with non-small cell lung cancer with EGFR exon 20 insertion mutations
3 July 2024 - Phase 3 PAPILLON study showed Rybrevant in combination with carboplatin and pemetrexed significantly improved progression-free survival, ...
Posted by Michael Wonder on 03 Jul 2024
Gadopiclenol as an MRI contrast agent: first benefit assessment of a diagnostic agent
1 July 2024 - For the first time, IQWiG has evaluated a drug that is a diagnostic agent within the ...
Posted by Michael Wonder on 03 Jul 2024
China’s National Medical Products Administration Approves Xtandi (enzalutamide) in metastatic hormone sensitive prostate cancer
2 July 2024 - Approval marks Xtandi’s third indication for advanced prostate cancer in China. ...
Posted by Michael Wonder on 03 Jul 2024
Johnson & Johnson receives approval from US FDA and European Commission for Sirturo (bedaquiline)
2 July 2024 - Johnson & Johnson announced today that the US FDA has issued traditional approval for Sirturo (bedaquiline) ...
Posted by Michael Wonder on 03 Jul 2024
CSL Behring’s haemophilia B drug Idelvion gets insurance coverage
2 July 2024 - CSL Behring's long-acting hemophilia B treatment Idelvion (albutrepenonacog alfa) has come to receive reimbursement in Korea. ...
Posted by Michael Wonder on 03 Jul 2024
Dupixent (dupilumab) approved in the European Union as the first ever targeted therapy for patients with COPD
3 July 2024 - First in world approval of Dupixent for adults with uncontrolled COPD with raised blood eosinophils based on ...