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RSS FeedPosted by Michael Wonder on 01 Dec 2023
FDA grants accelerated approval to pirtobrutinib for chronic lymphocytic leukaemia and small lymphocytic lymphoma
1 December 2023 - Today, the FDA granted accelerated approval to pirtobrutinib (Jaypirca, Eli Lilly) for adults with chronic lymphocytic ...
Posted by Michael Wonder on 30 Nov 2023
FDA grants priority review for supplemental biologics license application of Padcev (enfortumab vedotin-ejfv) with Keytruda (pembrolizumab) for first-line treatment of advanced bladder cancer
30 November 2023 - Results of pivotal confirmatory trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall survival and ...
Posted by Michael Wonder on 30 Nov 2023
Oxford BioTherapeutics announces partner Boehringer Ingelheim received US FDA fast track designation for BI 764532 for the potential treatment of advanced or metastatic large-cell neuroendocrine carcinoma of the lung
29 November 2023 - This is the third fast track designation for BI 764532. ...
Posted by Michael Wonder on 29 Nov 2023
FDA investigating serious risk of T-cell malignancy following BCMA directed or CD19 directed autologous chimeric antigen receptor (CAR) T cell immunotherapies
28 November 2023 - The FDA has received reports of T-cell malignancies, including chimeric antigen receptor CAR positive lymphoma, in ...
Posted by Michael Wonder on 28 Nov 2023
FDA fast track designation granted for Vaxinia trial program
28 November 2023 - FDA fast track designation for bile duct cancer granted for CF33-hNIS (Vaxinia) MAST clinical program. ...
Posted by Michael Wonder on 28 Nov 2023
Autolus Therapeutics submits biologics license application to US FDA for obecabtagene autoleucel (obe-cel) for patients with relapsed/refractory adult B-cell acute lymphoblastic leukaemia
27 November 2023 - BLA submission includes results from pivotal Phase 2 FELIX study evaluating obe-cel in relapsed/refractory adult B-cell acute ...
Posted by Michael Wonder on 28 Nov 2023
Genelux Corporation receives FDA fast track designation for olvi-vec in platinum resistant/refractory ovarian cancer
27 November 2023 - Pivotal Phase 3 study of olvi-vec in platinum resistant/refractory ovarian cancer initiated in September 2022. ...
Posted by Michael Wonder on 27 Nov 2023
FDA approves nirogacestat for desmoid tumours
27 November 2023 - Today, the FDA approved nirogacestat (Ogsiveo, SpringWorks Therapeutics) for adult patients with progressing desmoid tumours who ...
Posted by Michael Wonder on 27 Nov 2023
AbbVie announces US FDA and EMA updates for epcoritamab (Epkinly/Tepkinly) for the treatment of relapsed/refractory follicular lymphoma
27 November 2023 - Updates are supported by data from the Phase 1/2 EPCORE NHL-1 clinical trial. ...
Posted by Michael Wonder on 21 Nov 2023
FDA faces reckoning over short-cut drug approvals
21 November 2023 - Most people probably assume that all prescription drugs on the US market have been proven effective in ...
Posted by Michael Wonder on 20 Nov 2023
US FDA approves FoundationOne CDx as a companion diagnostic for AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) to identify patients with HR positive, HER2 negative advanced breast cancer
20 November 2023 - Foundation Medicine today announced that it has received approval from the US FDA for FoundationOne CDx ...
Posted by Michael Wonder on 20 Nov 2023
Janssen submits supplemental biologics license application to US FDA seeking approval of Rybrevant (amivantamab-vmjw) plus chemotherapy for the treatment of patients with EGFR mutated non-small-cell lung cancer who progressed on or after osimertinib
20 November 2023 - This submission is supported by data from the Phase 3 MARIPOSA-2 Study featured in a Late-Breaking Presidential ...
Posted by Michael Wonder on 20 Nov 2023
Bristol Myers Squibb and 2seventy bio provide update on US FDA review of sBLA for Abecma (idecabtagene vicleucel) in earlier lines of therapy for triple-class exposed relapsed or refractory multiple myeloma
20 November 2023 - Bristol Myers Squibb and 2seventy bio today announced the US FDA Oncologic Drugs Advisory Committee will ...
Posted by Michael Wonder on 18 Nov 2023
Polaris Group initiates rolling submission of biologic license application for ADI-PEG 20 with US FDA to treat malignant pleural mesothelioma
16 November 2023 - Polaris Group today announced that the Company has initiated the rolling submission of its biologic license ...
Posted by Michael Wonder on 17 Nov 2023
Pfizer and Astellas' Xtandi approved by US FDA in earlier prostate cancer treatment setting
16 November 2023 - Xtandi becomes the first and only androgen receptor signalling inhibitor approved for use with or without a ...