Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 28 Aug 2025
Rinvoq (upadacitinib) receives Health Canada notice of compliance for giant cell arteritis in adults
27 August 2025 - This marks the eighth approved indication for Rinvoq in Canada across rheumatology, gastro-enterology and dermatology. ...
Posted by Michael Wonder on 27 Aug 2025
Zemcelpro (UM171 cell therapy) receives EC authorisation as the first and only cell therapy for blood cancer patients without access to suitable donor cells
27 August 2025 - ExCellThera announced today the conditional marketing authorisation of Zemcelpro by the European Commission for the treatment of ...
Posted by Michael Wonder on 27 Aug 2025
Gadoquatrane new drug application accepted for review by US FDA
26 August 2025 - Bayer today announced that a new drug application for its investigational contrast agent gadoquatrane has been accepted ...
Posted by Michael Wonder on 27 Aug 2025
Leo Pharma announces Health Canada approval of Anzupgo for treatment of moderate to severe chronic hand eczema
26 August 2025 - Approval was based on results from the DELTA 1 and 2 trials, which evaluated the safety and ...
Posted by Michael Wonder on 27 Aug 2025
Cereno Scientific granted FDA fast track designation for CS1 in rare disease pulmonary arterial hypertension
26 August 2025 - Cereno Scientific today announced that the US FDA has granted fast track designation to its lead program, ...
Posted by Michael Wonder on 27 Aug 2025
Genmab receives FDA breakthrough therapy designation for rinatabart sesutecan in advanced endometrial cancer
t26 August 2025 - Genmab announced today that the US FDA has granted breakthrough therapy designation to rinatabart sesutecan, an investigational ...
Posted by Michael Wonder on 26 Aug 2025
Allarity Therapeutics granted FDA fast track designation for stenoparib for the treatment of advanced ovarian cancer
26 August 2025 - Allarity Therapeutics today announced that the US FDA has granted fast track designation to stenoparib, its investigational ...
Posted by Michael Wonder on 26 Aug 2025
Repatha now indicated for adults at increased risk for major adverse cardiovascular events due to uncontrolled LDL-C
25 August 2025 - Amgen today announced that the US FDA has broadened the approved use of Repatha (evolocumab) to include ...
Posted by Michael Wonder on 26 Aug 2025
European Commission authorises twice yearly Yeytuo (lenacapavir) for HIV prevention
26 August 2025 - Accelerated EC decision comes after US FDA approval in June. ...
Posted by Michael Wonder on 26 Aug 2025
Ayrmid announces FDA acceptance and priority review for omidubicel for the treatment of severe aplastic anaemia
25 August 2025 - Ayrmid today announced that the US FDA has accepted the Company’s priority review application for omidubicel for ...
Posted by Michael Wonder on 26 Aug 2025
Enhertu approved in Japan as first HER2 directed medicine for patients with HER2 low or HER2 ultra-low metastatic breast cancer following at least one endocrine therapy
25 August 2025 - Based on DESTINY-Breast06 phase 3 trial results that showed Enhertu demonstrated superiority versus chemotherapy with a ...
Posted by Michael Wonder on 26 Aug 2025
Datroway approved in China for patients with previously treated metastatic HR positive, HER2 negative breast cancer
25 August 2025 - First approval in China for Daiichi Sankyo and AstraZeneca’s Datroway based on TROPIONBreast01 results showing 37% reduction ...
Posted by Michael Wonder on 26 Aug 2025
Rusfertide receives breakthrough therapy designation for treatment of erythrocytosis in patients with polycythemia vera
25 August 2025 - Breakthrough therapy designation complements rusfertide's orphan drug and fast track designations, which together confer multiple benefits to ...
Posted by Michael Wonder on 25 Aug 2025
Moderna receives Health Canada approval for updated COVID-19 vaccine targeting SARS-CoV-2 variant LP.8.1
22 August 2025 - All 2025 pre-filled syringe doses to be made in Canada, marking a domestic production milestone. ...
Posted by Michael Wonder on 25 Aug 2025
Health Canada approves Roche’s Columvi (glofitamab) as the first bi-specific antibody in Canada for relapsed or refractory diffuse large B-cell lymphoma after initial therapy
21 August 2025 - Approval is based on Phase 3 STARGLO study where Columvi in combination with chemotherapy showed a ...