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RSS FeedPosted by Michael Wonder on 02 Apr 2025
Denali Therapeutics announces initiation of BLA filing for accelerated approval of tividenofusp alfa for the treatment of Hunter syndrome
2 April 2025 - Rolling submission of BLA initiated for tividenofusp alfa; preparations ongoing for potential US commercial launch in late ...
Posted by Michael Wonder on 31 Mar 2025
IDEAYA Biosciences receives US FDA breakthrough therapy designation for darovasertib monotherapy in neo-adjuvant uveal melanoma
31 March 2025 - Breakthrough therapy application was supported by updated clinical data from Phase 2 neo-adjuvant uveal melanoma trial that ...
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
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 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 27 Mar 2025
FDA approves cabozantinib for adults and paediatric patients 12 years of age and older with pNET and epNET
26 March 2025 - Today, the FDA approved cabozantinib (Cabometyx, Exelixis) for adult and paediatric patients 12 years of age ...
Posted by Michael Wonder on 20 Mar 2025
FDA approves pembrolizumab for HER2 positive gastric or gastro-oesophageal junction adenocarcinoma expressing PD-L1
19 March 2025 - Today, the FDA granted traditional approval to pembrolizumab (Keytruda, Merck) with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy ...
Posted by Michael Wonder on 20 Mar 2025
Azercabtagene zapreleucel granted FDA fast track designation in blood cancer DLBCL
19 March 2025 - Imugene is pleased to announce that the US FDA has granted fast track designation to its ...
Posted by Michael Wonder on 05 Mar 2025
Tevimbra approved in US for first-line treatment of advanced oesophageal squamous cell carcinoma in combination with chemotherapy
4 March 2025 - New indication based on results from a global Phase 3 trial demonstrating significantly improved overall survival ...
Posted by Michael Wonder on 26 Feb 2025
Pyxis Oncology granted FDA fast track designation for PYX-201 monotherapy in patients with recurrent or metastatic head and neck cancer
26 February 2025 - Pyxis Oncology today announced that the US FDA has granted fast track designation to PYX-201 for the ...
Posted by Michael Wonder on 26 Feb 2025
Odronextamab BLA accepted for FDA review for the treatment of relapsed/refractory follicular lymphoma
26 February 2025 - FDA decision expected by 30 July 2025. ...
Posted by Michael Wonder on 25 Feb 2025
FDA grants priority review to Merck’s application for Keytruda (pembrolizumab) plus standard of care as peri-operative treatment for resectable locally advanced head and neck squamous cell carcinoma
25 February 2025 - Acceptance based on results from the KEYNOTE-689 trial: the first Phase 3 trial to demonstrate significant improvement ...
Posted by Michael Wonder on 24 Feb 2025
US FDA grants fast track designation to Coherent Biopharma’s CBP-1019
21 February 2025 - Coherent Biopharma announced that the US FDA has granted fast track designation to CBP-1019 for the treatment ...
Posted by Michael Wonder on 24 Feb 2025
Auron Therapeutics announces AUTX-703 granted fast track designation by the FDA for relapsed or refractory acute myelogenous leukaemia
24 February 2025 - Auron Therapeutics today announced that the US FDA has granted fast track designation to AUTX-703 for ...
Posted by Michael Wonder on 24 Feb 2025
US FDA accepts BMS’s supplemental biologics license application for Opdivo plus Yervoy for patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer
24 February 2025 - Application based on analyses from the Phase 3 CheckMate-8HW clinical trial, in which Opdivo plus Yervoy demonstrated ...