Blog
RSS FeedPosted by Michael Wonder on 20 May 2024
Global cooperation and early access—clinical outcomes matter
13 May 2024 - In modern cancer drug development, surrogate measures are commonly used as clinical trial endpoints instead of more ...
Posted by Michael Wonder on 20 May 2024
Overall survival benefits of cancer drugs initially approved by the US FDA on the basis of immature survival data: a retrospective analysis
13 May 2024 - New cancer drugs can be approved by the US FDA on the basis of surrogate endpoints while ...
Posted by Michael Wonder on 18 May 2024
FDA withdraws accelerated approval to infigratinib for metastatic cholangiocarcinoma
16 May 2024 - Today, the FDA announced the final withdrawal of the approval of infigratinib (Truseltiq) for previously treated, ...
Posted by Michael Wonder on 17 May 2024
HLB shares plummet following FDA rejection of liver cancer drug approval
17 May 2024 - HLB revealed that its US subsidiary, Elevar Therapeutics, and their Chinese partner, Jiangsu Hengrui Pharmaceuticals, received ...
Posted by Michael Wonder on 17 May 2024
Health Canada approves Saladax’s 5-fluorouracil chemotherapy therapeutic drug monitoring test
14 May 2024 - Saladax Biomedical is pleased to announce that Health Canada has approved Saladax’s 5-Fluorouracil (My5-FU) Assay for sale ...
Posted by Michael Wonder on 16 May 2024
Nuvalent receives US FDA breakthrough therapy designation for NVL-655
16 May 2024 - Nuvalent today announced that the US FDA has granted breakthrough therapy designation to NVL-655 for the ...
Posted by Michael Wonder on 16 May 2024
FDA grants accelerated approval to tarlatamab-dlle for extensive stage small cell lung cancer
16 May 2024 - Today, the FDA granted accelerated approval to tarlatamab-dlle (Imdelltra, Amgen) for extensive stage small cell lung ...
Posted by Michael Wonder on 16 May 2024
Tisagenlecleucel for the treatment of patients with relapsed or refractory B-cell acute lymphoblastic leukaemia
15 May 2024 - NICE has published final evidence-based recommendations on the use of tisagenlecleucel (Kymriah) for the treatment of ...
Posted by Michael Wonder on 16 May 2024
Selinexor in combination with bortezomib and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma (final guidance)
15 May 2024 - NICE has published final evidence-based recommendations on the use of selinexor (Nexpovio) in combination with bortezomib ...
Posted by Michael Wonder on 15 May 2024
FDA grants accelerated approval to lisocabtagene maraleucel for follicular lymphoma
15 May 2024 - Today, the FDA granted accelerated approval to lisocabtagene maraleucel (Breyanzi, Juno Therapeutics) for adults with relapsed ...
Posted by Michael Wonder on 14 May 2024
Effect of Project Orbis participation by the Swiss regulator on submission gaps, review times, and drug approval decisions between 2020 and 2022: a comparative analysis
13 May 2024 - Expedited market access for novel and efficacious drugs is warranted for patients. Since 2020, Swissmedic (The Swiss ...
Posted by Michael Wonder on 13 May 2024
Petosemtamab granted breakthrough therapy designation by the US FDA
13 May 2023 - Merus today announced that the US FDA has granted breakthrough therapy designation for petosemtamab for the ...
Posted by Michael Wonder on 13 May 2024
Zai Lab announces approval of Augtyro (repotrectinib) for patients with ROS1 positive NSCLC by China’s NMPA
12 May 2024 - The approval is based on the pivotal TRIDENT-1 trial, in which Augtyro achieved a high response ...
Posted by Michael Wonder on 11 May 2024
Health Canada approves Keytruda for adult patients with locally advanced unresectable or metastatic biliary tract carcinoma, in combination with gemcitabine-based chemotherapy
9 May 2024 - Approval is based on the Phase 3 KEYNOTE-966 Trial. ...
Posted by Michael Wonder on 10 May 2024
SN Bioscience receives FDA fast track designation for small cell lung cancer
9 May 2024 - SN Bioscience announced on 7 May that the FDA has granted fast track designation for small cell ...