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RSS FeedPosted by Michael Wonder on 23 Jan 2026
Minimal residual disease and complete response in multiple myeloma: use as outcomes to support accelerated approval
20 January 2026 - This guidance provides recommendations to sponsors about using minimal residual disease and complete response in multiple myeloma ...
Posted by Michael Wonder on 23 Jan 2026
Enhertu approved in China as the first and only HER2 directed ADC for the second-line treatment of patients with HER2 positive metastatic gastric cancer
22 January 2026 - Based on DESTINY-Gastric04 Phase 3 trial results that showed Enhertu demonstrated a statistically significant and clinically ...
Posted by Michael Wonder on 23 Jan 2026
Guardant Health receives FDA approval for Guardant360 CDx as companion diagnostic for Braftovi (encorafenib) combination in patients with BRAF V600E mutant metastatic colorectal cancer
22 January 2026 - Approval supported by data from Pfizer’s BREAKWATER trial demonstrating improved outcomes in BRAF V600E-mutant metastatic colorectal cancer ...
Posted by Michael Wonder on 22 Jan 2026
BioNTech receives FDA fast track designation for mRNA cancer immunotherapy candidate BNT113 in HPV16+ head and neck cancer
21 January 2026 - BioNTech today announced that the US FDA has granted fast track designation to BNT113, an investigational mRNA ...
Posted 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 ...