Blog
RSS FeedPosted by Michael Wonder on 25 Jul 2025
Donanemab receives positive opinion from the CHMP in early symptomatic Alzheimer's disease
25 July 2025 - Eli Lilly and Company announced today that the EMA's CHMP has issued a positive opinion recommending donanemab ...
Posted by Michael Wonder on 25 Jul 2025
Cabometyx approved in the EU for previously treated advanced neuroendocrine tumours
24 July 2025 - Approval based on pivotal CABINET Phase 3 trial which demonstrated a 77% and 62% reduction in ...
Posted by Michael Wonder on 25 Jul 2025
Blenrep (belantamab mafodotin) combinations approved in EU for treatment of relapsed/refractory multiple myeloma
24 July 2025 - Two head-to-head Phase 3 trials demonstrated superior efficacy, including overall survival versus a daratumumab-based triplet in DREAMM-7. ...
Posted by Michael Wonder on 25 Jul 2025
Lisocabtagene maraleucel in follicular lymphoma: mysterious study discontinuation
15 July 2025 - The BMS has not provided any study data suitable for early benefit assessment. It initiated a randomised ...
Posted by Michael Wonder on 24 Jul 2025
Blenrep (belantamab mafodotin) combinations approved in Canada for the treatment of relapsed/refractory multiple myeloma
23 July 2025 - Superior efficacy shown in two head-to-head phase III trials, including overall survival in DREAMM-7. ...
Posted by Michael Wonder on 24 Jul 2025
Clearside Biomedical announces approval of Xipere suprachoroidal treatment for uveitic macular oedema in Canada
23 July 2025 - Clearside Biomedical announced today that Health Canada has granted approval for Xipere (triamcinolone acetonide injectable suspension) ...
Posted by Michael Wonder on 24 Jul 2025
Anzupgo (delgocitinib) cream is now the first and only FDA approved treatment for moderate to severe chronic hand eczema in adults
23 July 2025 - In Phase 3 clinical trials, patients experienced significant skin clearance along with marked relief from pain and ...
Posted by Michael Wonder on 23 Jul 2025
European Commission approves Imbruvica (ibrutinib) as the first targeted therapy for patients with previously untreated mantle cell lymphoma who would be eligible for autologous stem cell transplant
23 July 2025 - Data from the Phase 3 TRIANGLE study defines the fixed-duration ibrutinib-based regimen as a new standard of ...
Posted by Michael Wonder on 23 Jul 2025
European Commission approves Roche’s Itovebi for people with ER positive, HER2 negative, advanced breast cancer with a PIK3CA mutation
23 July 2025 - Approval based on INAVO120 data showing the Itovebi (inavolisib)-based regimen more than doubled progression-free survival compared with ...
Posted by Michael Wonder on 22 Jul 2025
Replimune receives complete response letter from FDA for RP1 biologics license application for the treatment of advanced melanoma
23 July 2025 - Replimune Group today announced that the US FDA has issued a complete response letter regarding the ...
Posted by Michael Wonder on 22 Jul 2025
Health Canada approves Keytruda for the treatment of adult patients with FIGO 2014 Stage III-IVA cervical cancer, in combination with chemoradiotherapy
21 July 2025 - Approval is based on the results from Phase 3 KEYNOTE-A18/ENGOT-cx11/GOG-30472 ...
Posted by Michael Wonder on 22 Jul 2025
Bayer’s Nubeqa (darolutamide) receives EU approval in third indication for patients with advanced prostate cancer
21 July 2025 - Approval is based on positive results from the pivotal Phase 3 ARANOTE trial and reinforces darolutamide’s established ...
Posted by Michael Wonder on 21 Jul 2025
Thousands could benefit from first immunotherapy for severe birch tree pollen allergy
21 July 2025 - We have recommended the first under the tongue tablet immunotherapy shown to build long-term tolerance to allergens, ...
Posted by Michael Wonder on 19 Jul 2025
MHRA approves adrenaline nasal spray - the first needle-free emergency treatment for anaphylaxis in the UK
18 July 2025 - The MHRA has today approved adrenaline nasal spray (EURneffy) to be used for the emergency treatment of ...
Posted by Michael Wonder on 18 Jul 2025
European Commission grants conditional approval of Ezmekly
18 July 2025 - Ezmekly is the first and only therapy to receive marketing authorisation in the EU for both adults ...