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RSS FeedPosted by Michael Wonder on 29 Jan 2026
Summit Therapeutics announces US FDA acceptance of biologics license application seeking approval for ivonescimab in combination with chemotherapy in treatment of patients with EGFRm NSCLC post-TKI therapy
29 January 2026 - Summit Therapeutics today announced that the US FDA has accepted for filing Summit's biologics license application seeking ...
Posted by Michael Wonder on 29 Jan 2026
Elevar Therapeutics submits new drug application to FDA for lirafugratinib as second-line treatment option for cholangiocarcinoma
28 January 2026 - Elevar Therapeutics today announced it submitted a new drug application to the US FDA for its investigational ...
Posted by Michael Wonder on 27 Jan 2026
Innovent announces IBI3003 (GPRC5D/BCMA/CD3 trispecific antibody) receives fast track designation from the US FDA for relapsed or refractory multiple myeloma
27 January 2026 - Innovent Biologics announced that its anti-GPRC5D/BCMA/CD3 tri-specific antibody IBI3003 has received fast track designation from the US ...
Posted by Michael Wonder on 27 Jan 2026
FDA approves daratumumab and hyaluronidase-fihj with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma
27 January 2026 - Today, the FDA approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech) in combination with bortezomib, lenalidomide, ...
Posted by Michael Wonder on 26 Jan 2026
Cogent Biosciences announces breakthrough therapy designation for bezuclastinib in combination with sunitinib for patients with gastro-intestinal stromal tumours
26 January 2026 - Cogent will submit the PEAK new drug application under previously announced RTOR designation; on track to complete ...
Posted 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
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
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 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 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 ...