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RSS FeedPosted by Michael Wonder on 19 Feb 2024
Datopotamab deruxtecan biologics license application accepted in the US for patients with previously treated advanced non-squamous non-small cell lung cancer
19 February 2024 - Application based on results from the TROPION-Lung01 Phase 3 trial. ...
Posted by Michael Wonder on 16 Feb 2024
FDA approves osimertinib with chemotherapy for EGFR mutated non-small-cell lung cancer
16 February 2024 - Today, the FDA approved osimertinib (Tagrisso, AstraZeneca) with platinum-based chemotherapy for patients with locally advanced or ...
Posted by Michael Wonder on 16 Feb 2024
FDA grants accelerated approval to lifileucel for unresectable or metastatic melanoma
16 February 2024 - Today, the FDA granted accelerated approval to lifileucel (Amtagvi, Iovance Biotherapeutics), a tumour derived autologous T ...
Posted by Michael Wonder on 15 Feb 2024
FDA approves tepotinib for metastatic non-small-cell lung cancer
15 February 2024 - Today, the FDA granted traditional approval to tepotinib (Tepmetko, EMD Serono) for adult patients with metastatic ...
Posted by Michael Wonder on 15 Feb 2024
Citius Pharmaceuticals resubmits the biologics license application of Lymphir (denileukin diftitox) for the treatment of adults with relapsed or refractory cutaneous T-cell lymphoma
13 February 2024 - FDA acceptance of the completed resubmission package and issuance of a Prescription Drug User Fee Act ...
Posted by Michael Wonder on 14 Feb 2024
US FDA accepts for priority review Bristol Myers Squibb’s application for Augtyro (repotrectinib) for the treatment of patients with NTRK positive locally advanced or metastatic solid tumours
14 February 2024 - The US FDA assigned a target action date of 15 June 2024. ...
Posted by Michael Wonder on 13 Feb 2024
CAN-3110 receives FDA fast track designation for treatment of recurrent high-grade glioma
13 February 2024 - Candel Therapeutics today announced that the US FDA granted fast track designation for CAN-3110 -- a first ...
Posted by Michael Wonder on 13 Feb 2024
FDA approves irinotecan liposome for first-line treatment of metastatic pancreatic adenocarcinoma
13 February 2024 - Today, the FDA approved irinotecan liposome (Onivyde, Ipsen) with oxaliplatin, fluorouracil, and leucovorin, for the first-line ...
Posted by Michael Wonder on 12 Feb 2024
RadioMedix and Orano Med receive FDA breakthrough therapy designation for AlphaMedix in gastro-enteropancreatic neuroendocrine tumours
12 February 2024 - First targeted alfa therapy to receive a breakthrough therapy designation. ...
Posted by Michael Wonder on 12 Feb 2024
BioXcel Therapeutics receives FDA fast track designation for BXCL701 for treatment of small cell neuroendocrine prostate cancer
12 February 2024 - BXCL701 is an investigational, oral innate immune activator designed to inflame the tumour microenvironment and augment CPI ...
Posted by Michael Wonder on 12 Feb 2024
FDA accepts Xspray Pharma’s NDA resubmission for Dasynoc
12 February 2024 - The US FDA has accepted the resubmission of Xspray Pharma’s new drug application for Dasynoc, following ...
Posted by Michael Wonder on 07 Feb 2024
Bristol Myers Squibb announces acceptance of US and EU regulatory filings for neo-adjuvant Opdivo (nivolumab) and chemotherapy followed by surgery and adjuvant Opdivo in resectable non-small cell lung cancer
7 February 2024 - Applications based on results from CheckMate-77T, the company’s second positive Phase 3 randomised trial with an immunotherapy-based ...
Posted by Michael Wonder on 06 Feb 2024
Arvinas and Pfizer’s vepdegestrant (ARV-471) receives FDA fast track designation for the treatment of patients with ER positive/HER2 negative metastatic breast cancer
6 February 2024 - Vepdegestrant is an investigational PROteolysis Targeting Chimera (PROTAC) protein degrader designed to target and degrade the ...
Posted by Michael Wonder on 05 Feb 2024
Ultimovacs receives FDA fast track designation for UV1 cancer vaccine for the treatment of patients with unresectable mesothelioma
5 February 2024 - The designation was granted by the US FDA based on results from the randomised Phase II clinical ...
Posted by Michael Wonder on 02 Feb 2024
Linvoseltamab receives EMA filing acceptance for treatment of relapsed/refractory multiple myeloma
2 February 2024 - Regeneron Pharmaceuticals today announced that the EMA has accepted for review the marketing authorisation application for linvoseltamab ...