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RSS FeedPosted by Michael Wonder on 04 Oct 2024
FDA approves neo-adjuvant/adjuvant nivolumab for resectable non-small cell lung cancer
3 October 2024 - Today, the FDA approved nivolumab (Opdivo, Bristol Myers Squibb) with platinum-doublet chemotherapy as neo-adjuvant treatment, followed ...
Posted by Michael Wonder on 03 Oct 2024
Calquence granted priority review in the US for patients with untreated mantle cell lymphoma
3 October 2024 - Submission to be reviewed under Project Orbis. ...
Posted by Michael Wonder on 03 Oct 2024
Volastra Therapeutics granted FDA fast track designation for novel KIF18A inhibitor in ovarian cancer
2 October 2024 - Volastra Therapeutics today announced that the US FDA has granted fast track designation to VLS-1488, the company’s ...
Posted by Michael Wonder on 02 Oct 2024
Johnson & Johnson files for US FDA approval of Darzalex Faspro based quadruplet regimen for newly diagnosed multiple myeloma patients for whom transplant is not planned
30 September 2024 - Results from CEPHEUS study highlight Darzalex Faspro quadruplet regimen as a potential standard of care in ...
Posted by Michael Wonder on 01 Oct 2024
Enhertu granted priority review in the US for patients with HER2 low or HER2 ultra-low metastatic breast cancer who have received at least one line of endocrine therapy
1 October 2024 - Based on DESTINY-Breast06 phase 3 trial which demonstrated a statistically significant and clinically meaningful progression-free survival ...
Posted by Michael Wonder on 29 Sep 2024
FDA approves selpercatinib for RET fusion-positive medullary thyroid cancer
27 September 2024 - Today, the FDA granted traditional approval to selpercatinib (Retevmo, Eli Lilly) for adult and paediatric patients ...
Posted by Michael Wonder on 29 Sep 2024
AbbVie submits biologics license application to the FDA for telisotuzumab vedotin in previously treated non-small cell lung cancer
27 September 2024 - Biologics license application submission for accelerated approval is supported by data from the Phase 2 LUMINOSITY trial ...
Posted by Michael Wonder on 28 Sep 2024
Bayer submits supplemental new drug application to US FDA seeking expanded indication for Nubeqa (darolutamide) in metastatic hormone-sensitive prostate cancer
26 September 2024 - Submission is based on positive results from the investigational pivotal Phase 3 ARANOTE trial that showed Nubeqa ...
Posted by Michael Wonder on 25 Sep 2024
FDA approves osimertinib for locally advanced, unresectable (stage III) non-small cell lung cancer following chemoradiation therapy
25 September 2024 - Today, the FDA approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals) for adult patients with locally advanced, unresectable (stage ...
Posted by Michael Wonder on 24 Sep 2024
Elevar Therapeutics resubmits new drug application to FDA for combination of camrelizumab plus rivoceranib as first-line treatment option for unresectable hepatocellular carcinoma boosted by CARES-310 leading overall survival analysis
23 September 2024 - Elevar Therapeutics today announced the resubmission of a new drug application to the US FDA for its ...
Posted by Michael Wonder on 24 Sep 2024
Elevation Oncology receives fast track designation from the FDA for EO-3021 for the treatment of adult patients with advanced or metastatic gastric or gastro-oesophageal junction cancer expressing Claudin 18.2
23 September 2024 - Elevation Oncology today announced that the US FDA has granted fast track designation to EO-3021, a differentiated ...
Posted by Michael Wonder on 21 Sep 2024
FDA fast track designation for narmafotinib in advanced pancreatic cancer
19 September 2024 - Amplia Therapeutics is pleased to announce that the US FDA has granted fast track designation to Amplia's ...
Posted by Michael Wonder on 20 Sep 2024
FDA approves isatuximab-irfc with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma
20 September 2024 - Today, the FDA approved isatuximab-irfc (Sarclisa, Sanofi-Aventis) with bortezomib, lenalidomide, and dexamethasone for adults with newly ...
Posted by Michael Wonder on 19 Sep 2024
FDA approves amivantamab-vmjw with carboplatin and pemetrexed for non-small cell lung cancer with EGFR exon 19 deletions or L858R mutations
19 September 2024 - Today, the FDA approved amivantamab-vmjw (Rybrevant, Janssen) with carboplatin and pemetrexed for adult patients with locally ...
Posted by Michael Wonder on 19 Sep 2024
ImCheck receives FDA fast track designation for ICT01 in combination with azacitidine and venetoclax in first-line acute myeloid leukaemia for patients unfit for induction chemotherapy treatment
18 September 2024 - ICT01, a humanised anti-butyrophilin 3A monoclonal antibody designed to selectively activate Vγ9Vδ2 T cells, has shown ...