Blog
RSS FeedPosted by Michael Wonder on 14 Jan 2025
FDA accepts Leqembi (lecanemab-irmb) biologics license application for subcutaneous maintenance dosing for the treatment of early Alzheimer’s disease
13 January 2025 - Eisai and Biogen announced today that the US FDA has accepted Eisai’s biologics license application for lecanemab-irmb ...
Posted by Michael Wonder on 13 Jan 2025
Datopotamab deruxtecan granted priority review in the US for patients with previously treated advanced EGFR mutated non-small cell lung cancer
13 January 2025 - Application based on TROPION-Lung05 Phase 2 trial and supported by data from TROPION-Lung01 Phase 3 and ...
Posted by Michael Wonder on 13 Jan 2025
GSK’s Shingrix new pre-filled syringe presentation accepted for review by US FDA
10 January 2025 - An FDA decision on the application is expected by 20 June 2025. ...
Posted by Michael Wonder on 13 Jan 2025
Bayer submits application to US FDA and to China’s CDE for new indication of finerenone for patients with common form of heart failure with high unmet medical need
10 January 2025 - Regulatory submissions are based on positive data from the Phase 3 FINEARTS-HF study recently presented at ESC ...
Posted by Michael Wonder on 12 Jan 2025
Important milestone for Biotest: biologics license application for fibrinogen submitted to the US FDA
9 January 2025 - The biologics license application for Biotest’s fibrinogen has been submitted to the US FDA. ...
Posted by Michael Wonder on 10 Jan 2025
Nipocalimab granted US FDA priority review for the treatment of generalized myasthenia gravis
9 January 2024 - Biologics license application acceptance supported by results from the Phase 3 Vivacity-MG3 study. ...
Posted by Michael Wonder on 10 Jan 2025
FDA accepts Agios’ supplemental new drug application for Pyrukynd (mitapivat) in adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia
8 January 2025 - Agios Pharmaceuticals today announced that the US FDA accepted the company’s supplemental new drug application for Pyrukynd ...
Posted by Michael Wonder on 09 Jan 2025
US FDA confirms class 1 resubmission of the supplemental new drug application for Izervay (avacincaptad pegol intravitreal solution) for geographic atrophy
8 January 2025 - Astellas today announced the US FDA accepted the revised supplemental new drug application for Izervay (avacincaptad ...
Posted by Michael Wonder on 08 Jan 2025
US FDA granted priority review to Dizal's sunvozertinib new drug application
7 January 2025 - Sunvozertinib's new drug application was submitted based on the multinational pivotal WU-KONG1 Part B study, the ...
Posted by Michael Wonder on 07 Jan 2025
EMA commences review of donidalorsen in hereditary angioedema
6 January 2025 - Otsuka announces that the EMA has accepted for review the marketing authorisation application for the hereditary ...
Posted by Michael Wonder on 07 Jan 2025
Norgine submits marketing authorisation application to the EMA for eflornithine (difluoromethylornithine) in high risk neuroblastoma
6 January 2025 - Norgine today announced that it completed its marketing authorisation application filing to the EMA for eflornithine in ...
Posted by Michael Wonder on 06 Jan 2025
Sentynl Therapeutics announces US FDA acceptance and priority review of new drug application for CUTX-101 (copper histidinate) product candidate for treatment of Menkes disease
6 January 2025 - Six month priority review granted for CUTX-101 copper histidinate with PDUFA target action date set for 30 ...
Posted by Michael Wonder on 03 Jan 2025
Capricor Therapeutics completes submission of biologics license application to the US FDA for deramiocel for the treatment of Duchenne muscular dystrophy
2 January 2024 - If approved, deramiocel would be first approved therapy for Duchenne muscular dystrophy cardiomyopathy. ...
Posted by Michael Wonder on 02 Jan 2025
NRx Pharmaceuticals files initial section of US new drug application to the FDA for NRX-100 (IV ketamine) for the treatment of suicidal depression
30 December 2024 - Aiming to be the first FDA approved medication to treat suicidal depression. ...
Posted by Michael Wonder on 01 Jan 2025
Corcept submits new drug application for relacorilant as a treatment for patients with hypercortisolism
30 December 2024 - Corcept Therapeutics has submitted a new drug application to the US FDA for its proprietary, selective cortisol ...