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RSS FeedPosted 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 ...
Posted by Michael Wonder on 24 Oct 2023
ImmunityBio announces biological license application resubmission for N-803 in BCG unresponsive non-muscle invasive bladder cancer carcinoma in situ
23 October 2023 - Following the type A meeting with the FDA, ImmunityBio has completed the BLA resubmission addressing the issues ...
Posted by Michael Wonder on 20 Oct 2023
FDA expands paediatric indication for entrectinib and approves new pellet formulation
20 October 2023 - Today, the FDA granted accelerated approval to entrectinib (Rozlytrek, Genentech) for paediatric patients older than 1 ...
Posted by Michael Wonder on 17 Oct 2023
Diakonos Oncology awarded FDA fast track designation for innovative dendritic cell vaccine for glioblastoma
17 October 2023 - Diakonos Oncology announced today that the US FDA has granted fast track designation for the Company’s unique ...
Posted by Michael Wonder on 16 Oct 2023
FDA approves neo-adjuvant/adjuvant pembrolizumab for resectable non-small cell lung cancer
16 October 2023 - Today, the FDA approved pembrolizumab (Keytruda, Merck) with platinum-containing chemotherapy as neo-adjuvant treatment, and with continuation ...
Posted by Michael Wonder on 16 Oct 2023
Tagrisso plus chemotherapy granted priority review in the US for patients with EGFR mutated advanced lung cancer
16 October 2023 - Decision based on FLAURA2 Phase 3 trial results which extended median progression-free survival by nearly 9 ...
Posted by Michael Wonder on 14 Oct 2023
US FDA approves Opdivo (nivolumab) as adjuvant treatment for eligible patients with completely resected stage IIB or stage IIC melanoma
13 October 2023 - In the Phase 3 CheckMate-76K trial, Opdivo demonstrated a statistically significant improvement in recurrence-free survival compared to ...
Posted by Michael Wonder on 12 Oct 2023
MimiVax granted fast track designation from FDA for SurVaxM for newly diagnosed glioblastoma
12 October 2023 - MimiVax announced today that the US FDA has granted fast track designation to MimiVax’s SurVaxM vaccine ...
Posted by Michael Wonder on 11 Oct 2023
FDA approves encorafenib with binimetinib for metastatic non-small cell lung cancer with a BRAF V600E mutation
11 October 2023 - Today, the FDA approved encorafenib (Braftovi, Array BioPharma, a wholly owned subsidiary of Pfizer) with binimetinib ...
Posted by Michael Wonder on 10 Oct 2023
US FDA approves FoundationOne CDx as a companion diagnostic for Lilly’s Retevmo (selpercatinib) for certain patients with solid tumours
9 October 2023 - Foundation Medicine’s tissue based comprehensive genomic profiling test is now FDA approved to identify patients with ...
Posted by Michael Wonder on 07 Oct 2023
Cancer drug shortage eases slightly, but it’s still ‘living from paycheck to paycheck’
5 October 2023 - The shortage of cancer drugs is not going away, but it may be easing slightly, a ...
Posted by Michael Wonder on 07 Oct 2023
EntroGen receives FDA approval for CRCdx RAS mutation detection kit as companion diagnostic for Vectibix
3 October 2023 - The US FDA has granted approval for EntroGen's CRCdx RAS Mutation Detection Kit as a companion diagnostic ...
Posted by Michael Wonder on 03 Oct 2023
Oxford BioTherapeutics announces partner Boehringer Ingelheim received US FDA fast track designation for BI 764532 for the treatment of extensive stage small cell lung cancer and extrapulmonary neuroendocrine cancers
3 October 2023 - BI 764532 is an investigational T-cell engager that redirects T cells towards cancer cells expressing the DLL3 ...
Posted by Michael Wonder on 03 Oct 2023
Takeda provides update on Exkivity (mobocertinib)
3 October 2023 - Takeda today announced that, following discussions with the US FDA, it will be working with the FDA ...
Posted by Michael Wonder on 02 Oct 2023
Avenge Bio receives FDA fast track designation for AVB-001, a novel cell therapy leveraging the LOCOcyte immunotherapy platform
2 October 2023 - Regulatory designation includes platinum-resistant, high grade serous adenocarcinoma of the ovary, primary peritoneum or fallopian tube. ...