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RSS FeedPosted 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 08 Jan 2025
Rezolute receives breakthrough therapy designation from FDA for ersodetug in the treatment of hypoglycaemia due to congenital hyperinsulinism
7 January 2025 - Breakthrough therapy designation granted based on key positive data from the Phase 2b (RIZE) study and current ...
Posted by Michael Wonder on 07 Jan 2025
GSK’s B7-H3 targeted antibody drug conjugate, GSK’227, receives US FDA breakthrough therapy designation in late-line relapsed or refractory osteosarcoma
7 January 2025 - Regulatory designation based on promising early data in this rare bone cancer. ...
Posted by Michael Wonder on 07 Jan 2025
Restem receives FDA fast track designation for Restem-L for idiopathic inflammatory myopathy
7 January 2025 - Second regulatory designation for Restem-L, a lead ULSC program, following the recent orphan drug designation. ...
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 06 Jan 2025
Star Therapeutics receives FDA fast track designation for VGA039 in von Willebrand disease
6 January 2025 - VGA039 is potentially the first subcutaneous therapy that addresses all types of von Willebrand disease and has a ...
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
Save the Food and Drug Administration by breaking it up
2 January 2025 - Let’s separate the FDA into two distinct entities. ...
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 27 Dec 2024
FDA approves nivolumab and hyaluronidase-nvhy for subcutaneous injection
27 December 2024 - Today, the FDA approved nivolumab and hyaluronidase-nvhy (Opdivo Qvantig, Bristol Myers Squibb) for subcutaneous injection across ...