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RSS FeedPosted by Michael Wonder on 21 Jan 2026
US FDA grants to Wugen’s WU-CART-007 breakthrough therapy designation for treatment of relapsed or refractory T cell acute lymphoblastic leukaemia / T cell lymphoblastic lymphoma
21 January 2026 - Wugen today announced that it has received breakthrough therapy designation from the US FDA for its ...
Posted by Michael Wonder on 21 Jan 2026
Brain cancer survivor who finished year 12 hoping medication can get PBS listing
20 January 2026 - Julia Greig never thought her daughter would finish year 12 after she was diagnosed with brain ...
Posted by Michael Wonder on 21 Jan 2026
LBL-024 (opamtistomig PD-L1/4-1BB bispecific antibody) granted fast track designation by the US FDA
14 January 2026 - The Company is pleased to announce that LBL-024 (opamtistomig), a PD-L1/4-1BB bispecific antibody, was granted fast ...
Posted by Michael Wonder on 21 Jan 2026
Truqap faces double barrier in Korea as NGS and drug reimbursement lag
20 January 2026 - As demand for next generation sequencing screening rises, a new drug for metastatic breast cancer faces ...
Posted by Michael Wonder on 20 Jan 2026
Celcuity announces FDA acceptance of new drug application for gedatolisib in HR+/HER2-/PIK3CA wild type advanced breast cancer
20 January 2026 - Celcuity today announced that the US FDA has accepted for filing its new drug application for gedatolisib ...
Posted by Michael Wonder on 20 Jan 2026
Lilly's sofetabart mipitecan receives US FDA's breakthrough therapy designation for the treatment of certain patients with platinum-resistant ovarian cancer
20 January 2025 - Eli Lilly and Company today announced that the US FDA has granted breakthrough therapy designation to sofetabart ...
Posted by Michael Wonder on 19 Jan 2026
Enhertu plus pertuzumab type II variation application validated in the EU as first-line treatment of patients with HER2 positive metastatic breast vancer
19 January 2026 - Based on DESTINY-Breast09 Phase 3 trial results that showed Daiichi Sankyo and AstraZeneca’s Enhertu in combination ...
Posted by Michael Wonder on 14 Jan 2026
US FDA grants Ipsen’s IPN60340 (ICT01) breakthrough therapy designation in first line unfit acute myeloid leukaemia
13 January 2025 - Ipsen announced today that the US FDA has granted breakthrough therapy designation for IPN60340 in combination with ...
Posted by Michael Wonder on 13 Jan 2026
Summit Therapeutics announces submission of biologics license application to US FDA seeking approval for ivonescimab in combination with chemotherapy in second-line (or later) treatment of patients with EGFRm NSCLC
12 January 2026 - Summit Therapeutics today announced that it has submitted a biologics license application to the US FDA seeking ...
Posted by Michael Wonder on 12 Jan 2026
FDA accepts new drug application for pimicotinib for the treatment of tenosynovial giant cell tumoir
12 January 2026 - Merck announced today that the US FDA has accepted the company’s new drug application for pimicotinib as ...
Posted by Michael Wonder on 09 Jan 2026
Revolution Medicines announces FDA breakthrough therapy designation for zoldonrasib
8 January 2026 - First breakthrough therapy designation for an investigational drug specifically targeting KRAS G12D mutation in non-small cell lung ...
Posted by Michael Wonder on 09 Jan 2026
858 Therapeutics announces FDA fast track designation for PARG inhibitor ETX-19477 for the treatment of patients with BRCA mutated, platinum resistant ovarian cancer
8 January 2026 - 858 Therapeutics today announced that the US FDA has granted fast track designation to ETX-19477, the company’s ...
Posted by Michael Wonder on 09 Jan 2026
Alessa Therapeutics announces FDA fast track designation for Enolen, a first of its kind treatment for localised prostate cancer
8 January 2026 - Alessa Therapeutics today announced that the US FDA has granted fast track designation for Enolen, the ...
Posted by Michael Wonder on 07 Jan 2026
Johnson & Johnson submits application to the EMA for Tecvayli (teclistamab) in combination with Darzalex (daratumumab) subcutaneous formulation for patients with relapsed/refractory multiple myeloma
5 January 2026 - The application is supported by data from the Phase 3 MajesTEC-3 study demonstrating a statistically significant improvement ...
Posted by Michael Wonder on 06 Jan 2026
Bayer receives breakthrough therapy designation in the US and China for sevabertinib as a first-line treatment for patients with HER2-mutant non-small cell lung cancer
6 January 2026 - Bayer receives breakthrough therapy designation in the US and China for sevabertinib as a first-line treatment for ...