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RSS FeedPosted by Michael Wonder on 09 Nov 2023
FDA amends pembrolizumab’s gastric cancer indication
9 November 2023 - On 7 November 2023, the FDA revised the existing indication of pembrolizumab (Keytruda, Merck) with trastuzumab, fluoropyrimidine, ...
Posted by Michael Wonder on 09 Nov 2023
US FDA accepts for priority review Bristol Myers Squibb’s application for Breyanzi (lisocabtagene maraleucel) for relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma
9 November 2023 - Application based on results from TRANSCEND CLL 004, the first pivotal multi-centre trial to show clinical benefit ...
Posted by Michael Wonder on 09 Nov 2023
Takeda receives US FDA approval of Fruzaqla (fruquintinib) for previously treated metastatic colorectal cancer
8 November 2023 - Fruzaqla is the first targeted therapy approved for metastatic colorectal cancer regardless of biomarker status or ...
Posted by Michael Wonder on 08 Nov 2023
FDA finalises guidance on real-time review of oncology drugs
7 November 2023 - The US FDA has finalised its guidance that outlines the eligibility and submission requirements for applicants interested ...
Posted by Michael Wonder on 01 Nov 2023
CStone announces NMPA approval of sugemalimab for patients with relapsed or refractory extranodal NK/T-cell lymphoma, the first anti-PD-1/PD-L1 mAb approved for this indication
31 October 2023 - Sugemalimab is the world’s first anti-PD-1/PD-L1 monoclonal antibody approved for relapsed or refractory extranodal NK/T-cell lymphoma indication. ...
Posted by Michael Wonder on 01 Nov 2023
FDA approves pembrolizumab with chemotherapy for biliary tract cancer
1 November 2023 - On 31 October 2023, the FDA approved pembrolizumab (Keytruda, Merck) to be used with gemcitabine and cisplatin ...
Posted by Michael Wonder on 31 Oct 2023
Day One announces FDA acceptance of NDA and priority review for tovorafenib in relapsed or progressive paediatric low grade glioma
30 October 2024 - Priority review granted with PDUFA target action date of 30 April 2024. ...
Posted by Michael Wonder on 30 Oct 2023
Sellas Life Sciences receives fast track designation from FDA for SLS009 for treatment of relapsed/refractory peripheral T-cell lymphomas
30 October 2023 - LS009 demonstrated promising efficacy in Phase 1 Study with 36.4% clinical response in relapsed/refractory peripheral T-cell lymphomas; ...
Posted by Michael Wonder on 30 Oct 2023
ArriVent receives FDA breakthrough therapy designation for furmonertinib for first-line treatment of advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations
30 October 2023 - ArriVent Biopharma today announced that the US FDA has granted breakthrough therapy designation for furmonertinib for ...
Posted by Michael Wonder on 29 Oct 2023
Coherus and Junshi Biosciences announce FDA pproval of Loqtorzi (toripalimab-tpzi) in all lines of treatment for recurrent or metastatic nasopharyngeal carcinoma
27 October 2023 - Loqtorzi is the first and only FDA approved treatment for nasopharyngeal carcinoma. ...
Posted by Michael Wonder on 26 Oct 2023
Oncternal Therapeutics announces FDA granted fast track designation for ONCT-534 for the treatment of metastatic castration-resistant prostate cancer
26 October 2023 - Oncternal Therapeutics today announced that the US FDA has designated ONCT-534, its novel dual-acting androgen receptor inhibitor, ...
Posted by Michael Wonder on 26 Oct 2023
FDA accepts ImmunityBio’s BLA resubmission as complete and sets new PDUFA date
26 October 2023 - A new PDUFA date of 23 April 2024 has been communicated by the Agency. ...
Posted by Michael Wonder on 26 Oct 2023
US FDA grants Paige breakthrough device designation for cancer detection in breast lymph nodes
26 October 2023 - Paige announced today that the US FDA has granted breakthrough device designation for Paige Lymph Node, an ...
Posted by Michael Wonder on 24 Oct 2023
Immatics receives FDA regenerative medicine advanced therapy designation for ACTengine IMA203 TCR-T monotherapy
24 October 2023 - Regulatory activities underway with an initial focus on a registration directed trial in melanoma as step ...
Posted by Michael Wonder on 24 Oct 2023
FDA approves ivosidenib for myelodysplastic syndromes
24 October 2023 - Today, the FDA approved ivosidenib (Tibsovo, Servier Pharmaceuticals) for adult patients with relapsed or refractory myelodysplastic ...