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RSS FeedPosted by Michael Wonder on 18 Sep 2024
Oncology accelerated approvals are often based on non-comparative trials evaluating response rate
17 September 2024 - Most oncology products granted accelerated approval by the US FDA tend to rely on non-comparative single ...
Posted by Michael Wonder on 17 Sep 2024
FDA approves pembrolizumab with chemotherapy for unresectable advanced or metastatic malignant pleural mesothelioma
17 September 2024 - Today, the FDA approved pembrolizumab (Keytruda, Merck) with pemetrexed and platinum chemotherapy as first-line treatment of ...
Posted by Michael Wonder on 17 Sep 2024
FDA approves ribociclib with an aromatase inhibitor and ribociclib and letrozole co-pack for early high-risk breast cancer
17 September 2024 - Today, the FDA approved ribociclib (Kisqali, Novartis) with an aromatase inhibitor for the adjuvant treatment of ...
Posted by Michael Wonder on 17 Sep 2024
Poseida Therapeutics receives regenerative medicine advanced therapy designation from FDA for P-BCMA-ALLO1 to treat relapsed/refractory multiple myeloma
16 September 2024 - FDA evaluated RMAT application based on positive clinical data from ongoing Phase 1 study of P-BCMA-ALLO1. ...
Posted by Michael Wonder on 12 Sep 2024
FDA approves atezolizumab and hyaluronidase-tqjs for subcutaneous injection
12 September 2024 - Today, the FDA approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech) for subcutaneous injection for all the ...
Posted by Michael Wonder on 09 Sep 2024
Amneal and Shilpa announce US FDA approval of Boruzu, the first ready to use version of bortezomib for subcutaneous administration
5 September 2024 - Ready to use oncology treatment used for multiple myeloma and mantle cell lymphoma. ...
Posted by Michael Wonder on 05 Sep 2024
Perspective Therapeutics granted fast track designation for VMT01 for the diagnosis and treatment of MC1R positive melanoma
5 September 2024 - Perspective Therapeutics today announced that the US FDA granted fast track designation for the development of ...
Posted by Michael Wonder on 05 Sep 2024
US FDA approves FoundationOne CDx and FoundationOne Liquid CDx as companion diagnostics for Lynparza (olaparib) in combination with abiraterone for patients with BRCA mutated metastatic castration-resistant prostate cancer
3 September 2024 - Foundation Medicine’s tissue and liquid biopsy tests can now be used to identify more patients who could ...
Posted by Michael Wonder on 05 Sep 2024
Innovent receives fast track designation from the US FDA for IBI363 (PD-1/IL-2α bispecific antibody fusion protein) as monotherapy for advanced melanoma
4 September 2024 - Innovent Biologics announced that the US FDA has granted fast track designation to its PD-1/IL-2α bispecific antibody ...
Posted by Michael Wonder on 03 Sep 2024
Obsidian Therapeutics receives FDA regenerative medicine advanced therapy designation for OBX-115 for the treatment of advanced melanoma
3 September 2024 - Obsidian Therapeutics today announced that the US FDA has granted regenerative medicine advanced therapy designation to ...
Posted by Michael Wonder on 03 Sep 2024
Caribou Biosciences announces the FDA has granted fast track designations to CB-010 in refractory SLE and to CB-012 in relapsed or refractory AML
3 September 2024 - Additional FDA designation for CB-010 following earlier RMAT and fast track designations in B-NHL. ...
Posted by Michael Wonder on 29 Aug 2024
FDA grants priority review to SpringWorks Therapeutics’ new drug application for mirdametinib for the treatment of adults and children with neurofibromatosis type 1-associated plexiform neurofibromas
28 August 2024 - PDUFA target action date of 28 February 2025. ...
Posted by Michael Wonder on 27 Aug 2024
FDA grants fast track designation for bexmarilimab
26 August 2024 - Faron Pharmaceuticals today announces that their lead candidate bexmarilimab has been granted fast track designation for the ...
Posted by Michael Wonder on 26 Aug 2024
BeiGene’s BGB-16673 receives US FDA fast track designation for CLL/SLL
26 August 2024 - Designation supported by promising safety and efficacy data from Phase 1/2 study in heavily pretreated patients with ...
Posted by Michael Wonder on 25 Aug 2024
FDA grants fast track designation to Aveta Biomics’ drug APG-157 for neo-adjuvant treatment of head and neck cancer
22 August 2024 - Aveta Biomics is pleased to announce that the US FDA has granted fast track designation to APG-157, ...