Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 20 Feb 2025
World’s first potential target therapy for diffuse gastric cancer granted fast track designation by the US FDA
20 February 2025 - Signet Therapeutics announced that the US FDA has granted fast track designation for SIGX1094, the world's first ...
Posted by Michael Wonder on 20 Feb 2025
Boehringer’s zongertinib receives priority review from US FDA for the treatment of HER2 (ERBB2)-mutant advanced non-small cell lung cancer
19 February 2025 - The application for this investigational treatment is based on positive results from the Phase Ib Beamion LUNG-1, ...
Posted by Michael Wonder on 20 Feb 2025
Clarity receives US FDA fast track designation for the treatment of metastatic castration resistant prostate cancer patients with copper Cu 67 SAR-bisPSMA
19 February 2025 - Clarity Pharmaceuticals is pleased to announce that the US FDA has granted fast track designation for ...
Posted by Michael Wonder on 18 Feb 2025
Petosemtamab granted breakthrough therapy designation by the US FDA for first-line PD-L1 positive head and neck squamous cell carcinoma
18 February 2025 - This marks the second breakthrough therapy designation for petosemtamab in head and neck squamous cell carcinoma. ...
Posted by Michael Wonder on 17 Feb 2025
Innovent receives second fast track designation from the US FDA for IBI363 (PD-1/IL-2α-bias bipspecific antibody fusion protein) in squamous non-small cell lung cancer
17 February 2025 - Innovent Biologics announced that its first in class PD-1/IL-2α-bias bi-specific antibody fusion protein, IBI363, has received its ...
Posted by Michael Wonder on 14 Feb 2025
FDA approves vimseltinib for symptomatic tenosynovial giant cell tumour
14 February 2025 - Today, the FDA approved vimseltinib (Romvimza, Deciphera Pharmaceuticals), a kinase inhibitor, for adult patients with symptomatic ...
Posted by Michael Wonder on 12 Feb 2025
OnCusp Therapeutics receives FDA fast track designation for CUSP06 for the treatment of platinum-resistant ovarian cancer
12 February 2025 - OnCusp Therapeutics today announced that the US FDA has granted fast track designation to CUSP06, a cadherin-6 ...
Posted by Michael Wonder on 12 Feb 2025
FDA approves brentuximab vedotin with lenalidomide and rituximab for relapsed or refractory large B-cell lymphoma
12 February 2025 - On 11 February 2025, the FDA approved brentuximab vedotin (Adcetris, Seagen) in combination with lenalidomide and a ...