Blog
RSS FeedPosted by Michael Wonder on 03 Dec 2024
The trade-off between accelerated cancer drug approvals and patient preferences
18 November 2024 - Cancer care stands at a critical juncture where the urgency of rapid drug approvals must be balanced ...
Posted by Michael Wonder on 03 Dec 2024
Shorla Oncology announces FDA approval of Imkeldi (imatinib) oral solution, an oral liquid for the treatment of certain forms of leukaemia and other cancers
25 November 2024 - Imkeldi marks Shorla Oncology’s fourth FDA Approval. ...
Posted by Michael Wonder on 02 Dec 2024
Blenrep combinations accepted for review by the US FDA for the treatment of relapsed/refractory multiple myeloma
25 November 2024 - Regulatory submission supported by Phase 3 head to head DREAMM-7 and DREAMM-8 trials showing statistically significant efficacy, ...
Posted by Michael Wonder on 30 Nov 2024
US FDA accepts supplemental new drug application for Nubeqa (darolutamide) for the treatment of patients with metastatic hormone sensitive prostate cancer
21 November 2024 - Submission based on positive results from the Phase 3 ARANOTE trial which showed Nubeqa (darolutamide) plus androgen ...
Posted by Michael Wonder on 30 Nov 2024
FDA approves updated drug labelling for fludarabine phosphate under Project Renewal
19 November 2024 - Today, the FDA approved updated drug labeling for fludarabine phosphate (Fludarabine Phosphate Injection, Sandoz) under Project ...
Posted by Michael Wonder on 29 Nov 2024
FDA grants accelerated approval to zanidatamab-hrii for previously treated unresectable or metastatic HER2 positive biliary tract cancer
20 November 2024 - Today, the FDA granted accelerated approval to zanidatamab-hrii (Ziihera, Jazz Pharmaceuticals), a bispecific HER2 directed antibody, ...
Posted by Michael Wonder on 29 Nov 2024
Replimune receives breakthrough therapy designation for RP1 and submits RP1 biologics license application to the FDA under the accelerated approval pathway
21 November 2024 - Replimune today announced that it has submitted a biologics license application to the FDA for RP1 (vusolimogene ...
Posted by Michael Wonder on 28 Nov 2024
US FDA approves FoundationOne Liquid CDx as a companion diagnostic for Tepmetko (tepotinib) to identify patients with MET exon 14 skipping alterations in non-small cell lung cancer
18 November 2024 - FoundationOne Liquid CDx is the first FDA approved companion diagnostic to identify patients who may be ...
Posted by Michael Wonder on 18 Nov 2024
Alentis receives FDA fast track designation for ALE.P02 for the treatment of CLDN1 positive squamous solid tumours
18 November 2024 - ALE.P02 is a first in class antibody-drug conjugate targeting CLDN1. ...
Posted by Michael Wonder on 17 Nov 2024
Azurity Pharmaceuticals announces FDA approval of Danziten (nilotinib) tablets, the first and only nilotinib with no mealtime restrictions
14 November 2024 - Azurity Pharmaceuticals announced today that the US FDA has approved Danziten, the first and only nilotinib with ...
Posted by Michael Wonder on 15 Nov 2024
FDA approves revumenib for relapsed or refractory acute leukaemia with a KMT2A translocation
15 November 2024 - Today, the FDA approved revumenib (Revuforj, Syndax Pharmaceuticals), a menin inhibitor, for relapsed or refractory acute ...
Posted by Michael Wonder on 12 Nov 2024
Datopotamab deruxtecan new BLA submitted for accelerated approval in the US for patients with previously treated advanced EGFR mutated non-small cell lung cancer
12 November 2024 - Daiichi Sankyo and AstraZeneca’s new application is based on the TROPION-Lung05 Phase 2 trial and supported ...
Posted by Michael Wonder on 09 Nov 2024
Caris Life Sciences receives FDA approval for MI Cancer Seek as a companion diagnostic test
6 November 2024 - MI Cancer Seek is the first and only simultaneous whole exome and whole transcriptome-based assay with ...
Posted by Michael Wonder on 08 Nov 2024
Dizal submits new drug application to the US FDA for sunvozertinib in treating relapsed or refractory non-small cell lung cancer with EGFR exon 20 insertion mutations
8 November 2024 - The submission is supported by data from the pivotal WU-KONG1 Part B study, which featured in an ...
Posted by Michael Wonder on 08 Nov 2024
Johnson & Johnson submits applications in the US and EU seeking approval of Darzalex Faspro/Darzalex as subcutaneous monotherapy for high risk smoldering multiple myeloma
8 November 2024 - If approved, Darzalex Faspro will become the first treatment option for patients with smoldering multiple myeloma at ...