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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
FDA grants priority review for Addyi (flibanserin) paving the way for expanded access to treat low sexual desire in post-menopausal women
24 July 2025 - Sprout Pharmaceuticals today announced that the US FDA has granted priority review for its supplemental application ...
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 24 Jul 2025
Verastem Oncology granted fast track designation for VS-7375 for the treatment of KRAS G12D mutated locally advanced or metastatic pancreatic cancer
24 July 2025 - Enrollment is on-going in US Phase 1/2a trial for VS-7375, an oral KRAS G12D (ON/OFF) inhibitor, ...
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
Commissioner's National Priority Voucher Pilot Program
22 July 2025 - Accelerated drug review for companies supporting US national interests. ...
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 24 Jul 2025
Revolution Medicines announces FDA breakthrough therapy designation for elironrasib
23 July 2025 - Designation based on encouraging clinical data observed with elironrasib in patients with advanced KRAS G12C non-small ...
Posted by Michael Wonder on 24 Jul 2025
Lilly to launch Mounjaro in Korea in August without reimbursement
23 July 2025 - Eli Lilly Korea is moving forward with the launch of its blockbuster Mounjaro (tirzepatide) next month, ...
Posted by Michael Wonder on 24 Jul 2025
Leriglitazone marketing authorisation application submitted for treatment of cerebral adrenoleukodystrophy has been validated by EMA
23 July 2025 - Minoryx Therapeutics and Neuraxpharm today announce that the marketing authorisation application for Minoryx’s lead candidate leriglitazone (Nezglyzal) ...
Posted by Michael Wonder on 24 Jul 2025
Solid Biosciences receives FDA fast track designation for SGT-501 first in class gene therapy for catecholaminergic polymorphic ventricular tachycardia
23 July 2025 - SGT-501 has now received FDA fast track, orphan drug and rare paediatric disease designations. ...
Posted by Michael Wonder on 23 Jul 2025
GSK announces extension of US FDA an review period for Blenrep (belantamab mafodotin-blmf) in relapsed/refractory multiple myeloma
23 July 2025 - New PDUFA date scheduled for 23 October 2025. ...
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 ...