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RSS FeedPosted by Michael Wonder on 29 Oct 2025
Alphamab Oncology announces biparatopic HER2 targeting ADC JSKN003 was granted fast track designation by FDA for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
28 October 2025 - Alphamab Oncology announced that the biparatopic HER2-targeting antibody drug conjugate JSKN003 has been granted fast track designation ...
Posted by Michael Wonder on 25 Oct 2025
Revolution Medicines awarded voucher for daraxonrasib (RMC-6236) under FDA Commissioner's National Priority Voucher Pilot Program
16 October 2025 - Revolution Medicines today announced that the US FDA has granted a non-transferrable voucher for daraxonrasib (RMC-6236), ...
Posted by Michael Wonder on 24 Oct 2025
FDA approves revumenib for relapsed or refractory acute myeloid leukaemia with a susceptible NPM1 mutation
24 October 2025 - Today, the FDA approved revumenib (Revuforj, Syndax Pharmaceuticals), a menin inhibitor, for relapsed or refractory acute ...
Posted by Michael Wonder on 24 Oct 2025
FDA grants priority review for Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), each in combination with Padcev (enfortumab vedotin-ejfv), for certain patients with muscle-invasive bladder cancer
23 October 2025 - Applications based on Phase 3 KEYNOTE-905 results showing the combination improved event-free survival by 60%, reduced the ...
Posted by Michael Wonder on 23 Oct 2025
Heidelberg Pharma’s lead ADC candidate HDP-101 granted fast track designation by US FDA for the treatment of multiple myeloma
23 October 2025 - Heidelberg Pharma today announced that HDP-101 (pamlectabart tismanitin), the Company’s lead amanitin-based ADC candidate, has been ...
Posted by Michael Wonder on 23 Oct 2025
Zenocutuzumab-zbco granted FDA breakthrough therapy designation for NRG1 positive cholangiocarcinoma
23 October 2025 - Partner Therapeutics today announced that the US FDA has granted breakthrough therapy designation to zenocutuzumab-zbco for the ...
Posted by Michael Wonder on 23 Oct 2025
FDA approves belantamab mafodotin-blmf for relapsed or refractory multiple myeloma
23 October 2025 - Today, the FDA approved belantamab mafodotin-blmf (Blenrep, GlaxoSmithKline), a B-cell maturation antigen (BCMA)-directed antibody and microtubule ...
Posted by Michael Wonder on 23 Oct 2025
Padcev (enfortumab vedotin-ejfv) plus Keytruda (pembrolizumab) sBLA granted FDA priority review for treatment of certain patients with muscle-invasive bladder cancer
21 October 2025 - Results from the pivotal EV-303 trial demonstrated that, when used before and after surgery, the combination reduced ...
Posted by Michael Wonder on 22 Oct 2025
Myosin Therapeutics receives FDA fast track designation for MT-125 in glioblastoma
22 October 2025 - Myosin Therapeutics today announced that the US FDA has granted fast track designation to MT-125 for the ...
Posted by Michael Wonder on 21 Oct 2025
Replimune announces FDA acceptance of BLA resubmission of RP1 for the treatment of advanced melanoma
20 October 2025 - Replimune today announced that the US FDA has accepted the resubmission of the biologics license application for ...
Posted by Michael Wonder on 20 Oct 2025
Cogent Biosciences announces FDA breakthrough therapy designation for bezuclastinib
20 October 2025 - Detailed results from bezuclastinib’s positive SUMMIT trial evaluating bezuclastinib in patients with non-advanced systemic mastocytosis planned for ...
Posted by Michael Wonder on 19 Oct 2025
Enterome receives FDA fast track designation in follicular lymphoma for lead OncoMimics immunotherapy EO2463
16 October 2025 - Enterome announces today that the US FDA has granted fast track designation for follicular lymphoma in the ...
Posted by Michael Wonder on 16 Oct 2025
NovelWise Pharmaceutical receives FDA fast track designation for NBM-BMX in metastatic uveal melanoma
14 October 2025 - NovelWise Pharmaceutical today announced that the US FDA has granted fast track designation for NBM-BMX, a ...
Posted by Michael Wonder on 14 Oct 2025
Akamis Bio receives FDA fast track designation for NG-350A for the treatment of mismatch repair proficient locally advanced rectal cancer
14 October 2025 - NG-350A is a systemically delivered oncolytic immunotherapy driving intra-tumoral expression of a CD40 agonist monoclonal antibody. ...
Posted by Michael Wonder on 13 Oct 2025
Bicara Therapeutics announces ficerafusp alfa granted breakthrough therapy designation by US FDA for first-line HPV negative metastatic or with unresectable, recurrent head and neck squamous cell carcinoma
13 October 2025 - Bicara Therapeutics today announced that the US FDA has granted breakthrough therapy designation to ficerafusp alfa in ...