Blog
RSS FeedPosted by Michael Wonder on 22 Aug 2024
Clarity receives FDA fast track designation for 64Cu-SAR-bisPSMA
22 August 2024 - Clarity Pharmaceuticals is pleased to announce that the US FDA has granted fast track designation for 64Cu-SAR-bisPSMA ...
Posted by Michael Wonder on 21 Aug 2024
Bristol Myers Squibb receives US Food and Drug Administration sBLA acceptance for first-line treatment of unresectable hepatocellular carcinoma
21 August 2024 - The US FDA assigned a target action date of 21 April 2025. ...
Posted by Michael Wonder on 21 Aug 2024
Regeneron provides update on biologics license application for linvoseltamab
20 August 2024 - Regeneron Pharmaceuticals today announced that the US FDA has issued a complete response letter for the biologics ...
Posted by Michael Wonder on 20 Aug 2024
GSK receives US FDA breakthrough therapy designation for its B7-H3 targeted antibody-drug conjugate in relapsed or refractory extensive-stage small-cell lung cancer
20 August 2024 - Regulatory designation based on promising early clinical evidence observed with GSK5764227 in this tumour type. ...
Posted by Michael Wonder on 20 Aug 2024
FDA approves lazertinib with amivantamab-vmjw for non-small lung cancer
20 August 2024 - On August 19, 2024, the FDA approved lazertinib (Lazcluze, Janssen Biotech) in combination with amivantamab-vmjw (Rybrevant, Janssen ...
Posted by Michael Wonder on 19 Aug 2024
Enhertu granted breakthrough therapy designation in US for certain patients with HER2 low or HER2 ultralow metastatic breast cancer
19 August 2024 - Daiichi Sankyo and AstraZeneca's Enhertu has now been granted eight breakthrough therapy designations with latest based ...
Posted by Michael Wonder on 16 Aug 2024
US FDA accepts for priority review Deciphera’s new drug application for vimseltinib for the treatment of patients with tenosynovial giant cell tumour
15 August 2024 - The US FDA has assigned a target action date of 17 February 2025. ...
Posted by Michael Wonder on 15 Aug 2024
FDA approves neo-adjuvant/adjuvant durvalumab for resectable non-small cell lung cancer
15 August 2024 - Today, the FDA approved durvalumab (Imfinzi, AstraZeneca) with platinum-containing chemotherapy as neo-adjuvant treatment, followed by single-agent ...
Posted by Michael Wonder on 15 Aug 2024
Accutar Biotechnology receives FDA fast track designation for AC699 in ER positive, HER2 negative breast cancer
14 August 2024 - Accutar Biotechnology announced today that the US FDA has granted the investigation of AC699 a fast track ...
Posted by Michael Wonder on 15 Aug 2024
Kiromic BioPharma’s Deltacel receives FDA fast track designation
14 August 2024 - Kiromic BioPharma announces that the US FDA has granted fast track designation to Deltacel (KB-GDT-01), the Company’s ...
Posted by Michael Wonder on 15 Aug 2024
UroGen submits completed UGN-102 NDA seeking approval as the first FDA approved treatment for low grade intermediate risk non-muscle invasive bladder cancer
14 August 2024 - UroGen Pharma today announced the successful completion of its new drug application submission for investigational drug UGN-102, ...
Posted by Michael Wonder on 09 Aug 2024
Citius Pharmaceuticals receives FDA approval for Lymphir (denileukin diftitox-cxdl) immunotherapy for the treatment of adults with relapsed or refractory cutaneous T-cell lymphoma
8 August 2024 - Lymphir is expected to launch within the next five months. ...
Posted by Michael Wonder on 06 Aug 2024
FDA approves vorasidenib for grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation
6 August 2024 - Today, the FDA approved vorasidenib (Voranigo, Servier Pharmaceuticals), an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) ...
Posted by Michael Wonder on 01 Aug 2024
FDA expands endometrial cancer indication for dostarlimab-gxly with chemotherapy
1 August 2024 - Today, the FDA approved dostarlimab-gxly (Jemperli, GSK) with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for ...
Posted by Michael Wonder on 01 Aug 2024
Guardant Health’s FDA approved Shield blood test now commercially available in US as a primary screening option for colorectal cancer
1 August 2024 - FDA approval announced earlier this week makes Shield first blood test that is approved for primary screening ...