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RSS FeedPosted by Michael Wonder on 31 Aug 2025
Moderna receives US FDA approval for updated COVID-19 vaccines targeting LP.8.1 variant of SARS-CoV-2
27 August 2025 - Moderna today announced that the US FDA has approved the supplemental biologics license applications for the ...
Posted by Michael Wonder on 31 Aug 2025
Pfizer and BioNTech’s Comirnaty receives US FDA approval for adults 65 and older and individuals ages 5 through 64 at increased risk for severe COVID-19
27 August 2025 - The 2025-2026 COVID-19 vaccine formulation targets the SARS-CoV-2 sub-lineage LP.8.1, in line with FDA guidance to more ...
Posted 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 31 Aug 2025
Sanofi’s Wayrilz approved in US as first BTK inhibitor for immune thrombocytopenia
29 August 2025 - Approval based on LUNA 3 Phase 3 study that demonstrated rapid and durable platelet response and improvements ...
Posted by Michael Wonder on 28 Aug 2025
European Commission approves Tevimbra as neo-adjuvant/adjuvant NSCLC treatment
27 August 2025 - Final analysis of RATIONALE-315 demonstrates clear overall survival benefit in peri-operative setting in resectable non-small cell lung ...
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 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. ...