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RSS FeedPosted 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 15 Jan 2025
Capivasertib in combination with fulvestrant for the treatment of patients with advanced, hormone receptor positive, HER2 negative breast cancer after endocrine treatment
14 January 2025 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
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
CAR T cell therapy Breyanzi (lisocabtagene maraleucel) approved for second-line relapsed or refractory diffuse large B-cell lymphoma
13 January 2024 - In the pivotal Phase 3 TRANSFORM trial, Breyanzi demonstrated a significant improvement in event-free survival over ...
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
Peter’s prostate cancer diagnosis came as a shock. Now, he wants to protect his kids.
14 January 2025 - Peter had no symptoms when he was diagnosed with prostate cancer. Now, he’d like to see an ...
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 ...
Posted by Michael Wonder on 12 Jan 2025
BridgeBio Oncology Therapeutics granted US FDA fast track designation for BBO-8520 for KRASG12C mutated metastatic non-small cell lung cancer
9 January 2025 - The US FDA has granted fast track designation to BBO-8520 for the treatment of adult patients with ...
Posted by Michael Wonder on 12 Jan 2025
Mersana Therapeutics announces additional FDA fast track designation granted to emiltatug ledadotin (XMT-1660)
10 January 2025 - Mersana Therapeutics today announced the US FDA recently granted an additional fast track designation to XMT-1660. ...
Posted by Michael Wonder on 10 Jan 2025
Erdafitinib for the treatment of patients with metastatic or unresectable FGFR altered urothelial cancer
9 January 2024 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 10 Jan 2025
Astellas receives Health Canada approval for Vyloy (zolbetuximab) in combination with chemotherapy for advanced gastric and gastro-oesophageal junction cancer
9 January 2024 - Canada's Drug Agency recently issued draft recommendation to reimburse Vyloy with conditions. ...
Posted by Michael Wonder on 09 Jan 2025
PureTech receives FDA fast track designation for LYT-200 in acute myeloid leukaemia
9 January 2024 - Single agent and combination data from Phase 1b AML/MDS trial presented at ASH 2024 showed potential of ...
Posted by Michael Wonder on 09 Jan 2025
Marengo’s first in class invikafusp alfa (STAR0602) receives US FDA fast track designation for treatment of unresectable, locally advanced, or metastatic colorectal cancers with high tumour mutational burden
8 January 2025 - Initial safety and efficacy data from Phase 1 STARt-001 trial showed promising single agent clinical activity ...
Posted by Michael Wonder on 08 Jan 2025
China's National Medical Products Administration approves Padcev in combination with Keytruda (pembrolizumab) for the treatment of advanced bladder cancer
8 January 2025 - NMPA approval based on the global Phase 3 EV-302 trial (also known as KEYNOTE-A39) where the ...
Posted by Michael Wonder on 08 Jan 2025
Korea's only RET inhibitor, Retevmo, seeks insurance coverage again
6 January 2025 - Lilly Korea is again pursuing reimbursement for Retevmo (selpercatinib), the only RET inhibitor in Korea. ...