21 February 2024 - Regeneron Pharmaceuticals today announced that the US FDA has accepted for priority review the biologics license application ...
20 February 2024 - In clinical studies, vorasidenib has demonstrated strong blood-brain barrier penetrance alongside clinically meaningful and statistically significant ...
20 February 2024 - Company expects multiple readouts from its Phase 1/2a clinical trial in 2024. ...
20 February 2024 - Acceptance based on results from the pivotal Phase 3 NRG-GY018 trial. ...
20 February 2024 - BMS today announced that the US FDA has accepted for priority review the supplemental new drug ...
19 February 2024 - Application based on results from the TROPION-Lung01 Phase 3 trial. ...
16 February 2024 - Today, the FDA approved osimertinib (Tagrisso, AstraZeneca) with platinum-based chemotherapy for patients with locally advanced or ...
16 February 2024 - Today, the FDA granted accelerated approval to lifileucel (Amtagvi, Iovance Biotherapeutics), a tumour derived autologous T ...
15 February 2024 - Today, the FDA granted traditional approval to tepotinib (Tepmetko, EMD Serono) for adult patients with metastatic ...
13 February 2024 - FDA acceptance of the completed resubmission package and issuance of a Prescription Drug User Fee Act ...
14 February 2024 - The US FDA assigned a target action date of 15 June 2024. ...
13 February 2024 - Candel Therapeutics today announced that the US FDA granted fast track designation for CAN-3110 -- a first ...
13 February 2024 - Today, the FDA approved irinotecan liposome (Onivyde, Ipsen) with oxaliplatin, fluorouracil, and leucovorin, for the first-line ...
12 February 2024 - First targeted alfa therapy to receive a breakthrough therapy designation. ...
12 February 2024 - BXCL701 is an investigational, oral innate immune activator designed to inflame the tumour microenvironment and augment CPI ...