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RSS FeedPosted 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 ...
Posted by Michael Wonder on 31 Dec 2024
Chimerix submits dordaviprone new drug application for accelerated approval to US FDA for patients with recurrent H3 K27M mutant diffuse glioma
30 December 2024 - Secures access of up to $30 million to support potential launch through Silicon Valley Bank credit ...
Posted by Michael Wonder on 31 Dec 2024
Precigen completes submission of BLA with request for priority review to the FDA for PRGN-2012 for the treatment of adults with recurrent respiratory papillomatosis
30 December 2024 - The BLA, under an accelerated approval pathway, is supported by data from the Phase 1/2 pivotal study ...
Posted by Michael Wonder on 31 Dec 2024
Verastem Oncology announces FDA acceptance and priority review of new drug application for avutometinib in combination with defactinib for the treatment of recurrent KRAS mutant low grade serous ovarian cancer
30 December 2024 - PDUFA target action date is 30 June 2025. ...
Posted by Michael Wonder on 30 Dec 2024
Telix files TLX250-CDx (Zircaix) BLA for kidney cancer imaging
30 December 2024 - Telix today announces that it has submitted its biologics license application to the US FDA for ...
Posted by Michael Wonder on 25 Dec 2024
Glaukos submits new drug application to US FDA for Epioxa
23 December 2024 - Glaukos today announced the submission of its new drug application to the US FDA for Epioxa, its ...
Posted by Michael Wonder on 24 Dec 2024
Datopotamab deruxtecan application in the EU for patients with advanced non-squamous non-small sell lung cancer voluntarily withdrawn
24 December 2024 - Daiichi Sankyo and AstraZeneca have voluntarily withdrawn the marketing authorisation application in the EU for datopotamab ...
Posted by Michael Wonder on 24 Dec 2024
US FDA accepts for priority review Nuvation Bio’s new drug application for taletrectinib for the treatment of advanced ROS1 positive non-small cell lung cancer
23 December 2024 - New drug application is based on pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies ...
Posted by Michael Wonder on 24 Dec 2024
Blarcamesine receives EMA filing acceptance for treatment of Alzheimer’s disease
23 December 2024 - Submission based on favourable ANAVEX 2-73-AD-004 trial results in patients with early Alzheimer’s disease. ...
Posted by Michael Wonder on 24 Dec 2024
Cytokinetics announces EMA validation of marketing authorisation application for aficamten for the treatment of obstructive hypertrophic cardiomyopathy
23 December 2024 - Cytokinetics today announced that the EMA has validated the marketing authorisation application for aficamten, a next in ...
Posted by Michael Wonder on 24 Dec 2024
Tonix Pharmaceuticals announces PDUFA goal date of 15 August 2025 for FDA decision on US marketing approval for TNX-102 SL for fibromyalgia
23 December 2024 - New drug application based on two statistically significant Phase 3 studies of TNX-102 SL for the ...