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RSS FeedPosted by Michael Wonder on 28 Aug 2025
MHRA approves zuranolone to treat postnatal depression in adults following childbirth
27 August 2025 - The MHRA has approved zuranolone (Zurzuvae) to treat moderate or severe postnatal depression in adults following childbirth. ...
Posted by Michael Wonder on 28 Aug 2025
Telix provides regulatory update on TLX250-CDx
28 August 2025 - Telix Pharmaceuticals today announces that it has received a complete response letter from the US FDA ...
Posted by Michael Wonder on 28 Aug 2025
Outlook Therapeutics provides regulatory update on US FDA review of ONS-5010/Lytenava (bevacizumab-vikg) for the treatment of wet AMD
28 August 2025 - Outlook Therapeutics plans to work with FDA to address the Agency’s issues. ...
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
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 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
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 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 ...
Posted by Michael Wonder on 25 Aug 2025
European Commission approves tablet formulation of BeOne Medicines’ Brukinsa for all approved indications
21 August 2025 - Tablets will advance treatment simplicity and convenience to meet patient needs across Europe. ...
Posted by Michael Wonder on 25 Aug 2025
Bewildering PBAC decision a missed opportunity to ensure Australian cancer patients not left behind
23 August 2025 - MSD Australia & New Zealand is astonished that after eight years of dialogue and consideration, the ...
Posted by Michael Wonder on 25 Aug 2025
Recommendations made the PBAC – July 2025
22 August 2025 - The recommendations from the July 2025 PBAC meeting are now available. ...