Blog
RSS FeedPosted by Michael Wonder on 28 Jan 2025
Enhertu approved in the US as first HER2 directed therapy for patients with HER2 low or HER2 ultralow metastatic breast cancer following disease progression after one or more endocrine therapies
27 January 2025 - Based on DESTINY-Breast06 phase 3 trial results which showed Enhertu demonstrated superiority versus chemotherapy with a ...
Posted by Michael Wonder on 27 Jan 2025
FDA grants priority review to Merck’s application for Welireg (belzutifan) for the treatment of patients with advanced pheochromocytoma and paraganglioma
27 January 2025 - Acceptance based on objective response rate data from the Phase 2 LITESPARK-015 trial evaluating WELIREG in certain ...
Posted by Michael Wonder on 24 Jan 2025
Clarity receives US FDA fast track designation for Cu 64 SAR-bisPSMA in biochemical recurrence of prostate cancer
24 January 2025 - Clarity Pharmaceuticals is pleased to announce that the US FDA has granted fast track designation for ...
Posted by Michael Wonder on 23 Jan 2025
Medexus announces FDA approval of Grapafex (treosulphan) for injection
22 January 2025 - Medexus will target a commercial launch in 1H CY2025; potential for annual product-level revenue to exceed ...
Posted by Michael Wonder on 22 Jan 2025
Replimune announces biologics license application acceptance and priority review for RP1 for the treatment of advanced melanoma
21 January 2025 - PDUFA action date of 22 July 2025, with priority review. ...
Posted by Michael Wonder on 19 Jan 2025
US FDA approves FoundationOne CDx as a companion diagnostic for Ojemda (tovorafenib) to treat the most common form of childhood brain tumour in paediatric patients
17 January 2025 - The approval supports the identification of therapeutic options for patients with relapsed or refractory BRAF altered paediatric ...
Posted by Michael Wonder on 17 Jan 2025
FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic, HR positive, HER2 negative breast cancer
17 January 2025 - Today, the FDA approved datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo), a Trop-2-directed antibody and topoisomerase inhibitor conjugate, ...
Posted by Michael Wonder on 17 Jan 2025
Innovent receives NMPA breakthrough therapy designation for IBI343 (anti-CLDN18.2 ADC) as monotherapy for advanced pancreatic cancer
16 January 2025 - Innovent Biologics announced that the Center for Drug Evaluation of China's National Medical Products Administration has granted ...
Posted by Michael Wonder on 16 Jan 2025
FDA approves sotorasib with panitumumab for KRAS G12C mutated colorectal cancer
16 January 2025 - Today, the FDA approved sotorasib (Lumakras, Amgen) with panitumumab (Vectibix, Amgen) for adult patients with KRAS ...
Posted by Michael Wonder on 16 Jan 2025
Foresee Pharmaceuticals announces the PDUFA goal date for the 3 month version of Camcevi is 29 August 2025
13 January 2025 - Foresee Pharmaceuticals announces that the US FDA issued a Day 74 letter. ...
Posted by Michael Wonder on 16 Jan 2025
FDA approves acalabrutinib with bendamustine and rituximab for previously untreated mantle cell lymphoma
16 January 2025 - Today, the FDA granted traditional approval to acalabrutinib (Calquence, AstraZeneca) with bendamustine and rituximab for adults ...
Posted by Michael Wonder on 15 Jan 2025
New drug application initiated with US FDA for TAR-200, the first and only intravesical drug releasing system for patients with BCG-unresponsive high-risk non-muscle-invasive bladder cancer
15 January 2025 - Application accepted for US FDA Real-Time Oncology Review based on Phase 2b SunRISe-1 study showing highest ...
Posted by Michael Wonder on 14 Jan 2025
Lokon Pharma receives FDA fast track designation for LOAd703 for the treatment of pancreatic cancer
10 January 2025 - Lokon Pharma today announced that the US FDA has granted fast track designation for the company´s product ...
Posted by Michael Wonder on 14 Jan 2025
Adaptimmune announces US FDA breakthrough therapy designation granted to letetresgene autoleucel for treatment of myxoid/round cell liposarcoma
13 January 2025 - Adaptimmune Therapeutics today announced that letetresgene autoleucel has been granted breakthrough therapy designation by the US ...
Posted by Michael Wonder on 13 Jan 2025
Datopotamab deruxtecan granted priority review in the US for patients with previously treated advanced EGFR mutated non-small cell lung cancer
13 January 2025 - Application based on TROPION-Lung05 Phase 2 trial and supported by data from TROPION-Lung01 Phase 3 and ...