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RSS FeedPosted by Michael Wonder on 08 Apr 2025
Datroway approved in the EU for patients with previously treated metastatic HR positive, HER2 negative breast cancer
8 April 2025 - Second DXd antibody drug conjugate approved in EU based on Daiichi Sankyo’s DXd technology ...
Posted by Michael Wonder on 08 Apr 2025
AbbVie announces European Commission approval of Rinvoq (upadacitinib) for the treatment of adults with giant cell arteritis
8 April 2025 - This marks the eighth approved indication for Rinvoq in the EU. ...
Posted by Michael Wonder on 08 Apr 2025
Teva announces FDA filing acceptance for Ajovy (fremanezumab) in paediatric episodic migraine prevention
7 April 2025 - If approved for an expanded paediatric indication, Ajovy would be the first calcitonin gene-related peptide antagonist for ...
Posted by Michael Wonder on 08 Apr 2025
European Commission approves expanded label for Kaftrio in combination with ivacaftor for people with cystic fibrosis
7 April 2025 - Approximately 4,000 people living with cystic fibrosis in the European Union are newly eligible for a ...
Posted by Michael Wonder on 08 Apr 2025
Allogene granted three US FDA fast track designations for ALLO-329, a next generation dual targeted CD19/CD70 allogeneic CAR T for the treatment of lupus, myositis and scleroderma
7 April 2025 - Phase 1 RESOLUTION trial initiation planned for mid-2025 with initial proof of concept by year end ...
Posted by Michael Wonder on 07 Apr 2025
European Commission approves subcutaneous Rybrevant (amivantamab) for the treatment of patients with advanced EGFR-mutated non-small cell lung cancer
7 April 2025 - European Commission approval based on positive results from the Phase 3 PALOMA-3 study. ...
Posted by Michael Wonder on 06 Apr 2025
Update on US FDA BLA for Novavax’s COVID-19 vaccine
2 April 2025 - Novavax can confirm that 1 April 2025, was the US FDA’s Prescription Drug User Fee Act date ...
Posted by Michael Wonder on 04 Apr 2025
Imfinzi-based peri-operative regimen approved in the EU for resectable non-small cell lung cancer
4 April 2025 - Approval based on AEGEAN Phase 3 trial results which showed a 32% reduction in the risk ...
Posted by Michael Wonder on 04 Apr 2025
Enhertu approved in the EU as first HER2 directed therapy for patients with HR positive, HER2 low or HER2 ultralow metastatic breast cancer following at least one endocrine therapy
4 April 2025 - Based on DESTINY-Breast06 phase 3 trial results which showed Enhertu demonstrated superiority versus chemotherapy with a ...
Posted by Michael Wonder on 04 Apr 2025
Aldeyra Therapeutics receives complete response letter from the US FDA for the reproxalap new drug application for the treatment of signs and symptoms of dry eye disease
3 April 2025 - Pending positive results and discussions with the FDA, new drug application resubmission expected mid 2025. ...
Posted by Michael Wonder on 04 Apr 2025
Helsinn submits a new formulation of Akynzeo to the EMA
2 April 2025 - Helsinn today announced the submission of a new formulation for Akynzeo to the EMA. ...
Posted by Michael Wonder on 04 Apr 2025
Bristol Myers Squibb receives positive CHMP opinion for the subcutaneous formulation of Opdivo (nivolumab) across multiple solid tumour indications
28 March 2025 - A decision on the EU Opdivo extension of marketing authorisation is expected by 2 June 2025 ...
Posted by Michael Wonder on 04 Apr 2025
Uplinza (inebulizumab-cdon) is now the first and only FDA approved treatment for IgG4 related disease
3 April 2025 - Uplinza shown to deliver corticosteroid-free, flare-free, complete remission for patients in the MITIGATE trial. ...
Posted by Michael Wonder on 03 Apr 2025
Platform clinical trials for the efficient evaluation of multiple treatments
31 March 2025 - For some medical conditions, including conditions without effective treatments, multiple promising but unproven therapies may exist, with ...
Posted by Michael Wonder on 03 Apr 2025
Novartis receives FDA accelerated approval for Vanrafia (atrasentan), the first and only selective endothelin A receptor antagonist for proteinuria reduction in primary IgA nephropathy
3 April 2025 - Phase 3 data showed Vanrafia achieved proteinuria reduction of 36.1% (P<0.0001) vs. placebo with improvements seen at ...