Blog
RSS FeedPosted 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 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 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
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
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 ...
Posted by Michael Wonder on 03 Apr 2025
Averoa receives positive opinion from the EMA for Xoancyl, an oral therapy for chronic kidney disease
2 April 2025 - Final European Commission decision expected by June 2025; UK regulatory submission foreseen via MHRA’s international recognition procedure. ...
Posted by Michael Wonder on 02 Apr 2025
Sydnexis announces positive CHMP opinion in Europe for SYD-101 for slowing the progression of paediatric myopia
1 April 2025 - Santen is Sydnexis’ licensing partner to commercialise SYD-101 within the EMEA region upon issuance of a ...
Posted by Michael Wonder on 02 Apr 2025
Valneva’s chikungunya vaccine Ixchiq now authorised in EU for adolescents aged 12 and above
1 April 2025 - With this extension, Ixchiq, the first vaccine against the chikungunya virus, is now available for administration ...
Posted by Michael Wonder on 02 Apr 2025
Efanesoctocog alfa for the treatment and prevention of bleeding episodes in patients with haemophilia A (final guidance)
2 April 2025 - NICE has published final evidence-based recommendations on the use of efanesoctocog alfa (Altuvoct) for the treatment ...
Posted by Michael Wonder on 02 Apr 2025
Rystiggo now approved for adults with generalised myasthenia gravis in Canada
2 April 2025 - The approval is supported by the pivotal Phase 3 MycarinG study in gMG, which demonstrated that treatment ...
Posted by Michael Wonder on 01 Apr 2025
Highlights from the 24-27 March 2025 CHMP meeting
28 March 2025 - The EMA’s CHMP recommended five medicines for approval at its March 2025 meeting. ...
Posted by Michael Wonder on 01 Apr 2025
European Commission approves Pfizer’s RSV vaccine Abrysvo to help protect adults aged 18-59 against RSV lower respiratory tract disease
1 April 2025 - Abrysvo is the first and only RSV vaccine approved in the European Union for non-pregnant adults ...