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RSS FeedPosted 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 ...
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 ...
Posted by Michael Wonder on 21 Dec 2024
Lexicon announces receipt of complete response letter for Zynquista (sotagliflozin)
20 December 2024 - Confirms previously disclosed and anticipated FDA decision. ...
Posted by Michael Wonder on 21 Dec 2024
Gilead submits new drug application to US FDA for twice yearly lenacapavir for HIV prevention
19 December 2024 - Lenacapavir named 2024 “Breakthrough of the Year” by Science Magazine. ...
Posted by Michael Wonder on 20 Dec 2024
US FDA issues complete response letter for the glepaglutide new drug application for the treatment of short bowel syndrome
19 December 2024 - The FDA concluded that Zealand Pharma’s application did not meet the full requirements for substantial evidence to ...
Posted by Michael Wonder on 20 Dec 2024
PTC Therapeutics announces vatiquinone NDA submission to FDA for the treatment of children and adults living with Friedreich ataxia
19 December 2024 - PTC's fourth approval application submitted to FDA in 2024. ...
Posted by Michael Wonder on 19 Dec 2024
Savara initiates rolling submission of a biologics license application to the US FDA for Molbreevi for the potential treatment of auto-immune pulmonary alveolar proteinosis
18 December 2024 - Company expects to complete BLA submission by end of Q1, 2025. ...
Posted by Michael Wonder on 19 Dec 2024
LIB Therapeutics submits a biologic license application to FDA for lerodalcibep for the treatment of adults with elevated LDL-cholesterol
16 December 2024 - Lerodalcibep is a novel, adnectin based, small protein binding, third generation PCSK9 inhibitor. ...