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RSS FeedPosted 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 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
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 ...