Blog
RSS FeedPosted by Michael Wonder on 01 Apr 2025
ICER publishes final evidence report on treatment for acute pain
31 March 2025 - Independent appraisal committee vote was split on the net health benefit of suzetrigine compared to non-systemic ...
Posted by Michael Wonder on 01 Apr 2025
Tivdak (tisotumab vedotin) approved by European Commission for previously treated recurrent or metastatic cervical cancer
31 March 2025 - In the global Phase 3 innovaTV 301 clinical trial Tivdak demonstrated superior overall survival compared to chemotherapy. ...
Posted by Michael Wonder on 01 Apr 2025
Bavarian Nordic receives US FDA approval of freeze dried smallpox and mpox vaccine
31 March 2025 - Bavarian Nordic today announced that the US FDA has approved the freeze dried formulation of Jynneos (smallpox ...
Posted by Michael Wonder on 31 Mar 2025
Calquence plus chemoimmunotherapy recommended for approval in the EU by CHMP as first and only BTK inhibitor for first-line mantle cell lymphoma
31 March 2025 - Recommendation based on ECHO Phase 3 trial results which demonstrated over 16 months of progression-free survival ...
Posted by Michael Wonder on 31 Mar 2025
Imfinzi approved in the US as first and only peri-operative immunotherapy for patients with muscle-invasive bladder cancer
31 March 2025 - Based on NIAGARA Phase 3 trial results which showed a 32% reduction in the risk of ...
Posted by Michael Wonder on 31 Mar 2025
Lilly’s statement about the CHMP opinion issued for donanemab
28 March 2025 - The EMA's CHMP issued an opinion that does not recommend Eli Lilly's donanemab be granted marketing ...
Posted by Michael Wonder on 31 Mar 2025
FDA expands Pluvicto’s metastatic castration-resistant prostate cancer indication
28 March 2025 - Today, the FDA expanded the indication for lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis Pharmaceuticals) to ...
Posted by Michael Wonder on 30 Mar 2025
Bristol Myers Squibb receives positive CHMP opinion for peri-operative regimen of neo-adjuvant Opdivo (nivolumab) and chemotherapy followed by surgery and adjuvant Opdivo for resectable non-small cell lung cancer in patients with tumour cell PD-L1 expression ≥1%
28 March 2025 - Recommendation based on Phase 3 CheckMate -77T trial showing significant event-free survival improvement when compared to neoadjuvant ...
Posted by Michael Wonder on 30 Mar 2025
World first as MHRA approves trofolastat for diagnostic imaging of prostate cancer in men
28 March 2025 - The MHRA has approved trofolastat (RoTecPSMA), the first prostate-specific membrane antigen (PSMA)-targeting product authorised for use with ...
Posted by Michael Wonder on 30 Mar 2025
FDA issues complete response letter for etripamil for PSVT
28 March 2025 - Complete response letter focused on CMC; no clinical issues relating to etripamil raised. ...
Posted by Michael Wonder on 29 Mar 2025
FDA approves durvalumab for muscle invasive bladder cancer
28 March 2025 - Today, the FDA approved durvalumab (Imfinzi, AstraZeneca) with gemcitabine and cisplatin as neo-adjuvant treatment, followed by ...
Posted by Michael Wonder on 29 Mar 2025
FDA approves novel treatment for haemophilia A or B, with or without factor inhibitors
28 March 2025 - Medication can be given up to once every 2 months. ...
Posted by Michael Wonder on 28 Mar 2025
Takeda’s HyQvia receives expanded market authorisation as maintenance therapy for chronic inflammatory demyelinating polyneuropathy
27 March 2025 - HyQvia is the only up to once monthly (every 2, 3 or 4 weeks) immunoglobulin subcutaneous ...
Posted by Michael Wonder on 28 Mar 2025
Neurim Pharmaceuticals receives European marketing authorisation for paediatric prolonged-release melatonin (Slenyto) for the treatment of insomnia in children with ADHD
26 March 2025 - Neurim Pharmaceuticals announces that the European Commission has approved the extension of the indication to include ...
Posted by Michael Wonder on 28 Mar 2025
Fresenius receives FDA approval for their denosumab biosimilars and secures global settlement agreement
27 March 2025 - Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht) received FDA approval for all indications of the reference products: Prolia (denosumab) ...