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RSS FeedPosted by Michael Wonder on 12 Feb 2024
FDA approves Takeda’s Eohilia (budesonide oral suspension), the first and only oral treatment in the US for eosinophilic oesophagitis
12 February 2024 - 12 weeks of treatment with Eohilia may address significant unmet needs of patients 11 years of age ...
Posted by Michael Wonder on 10 Feb 2024
Human acellular vessel biologics license application granted priority review by US FDA for the treatment of vascular trauma
9 February 2024 - PDUFA date set for 10 August 2024. ...
Posted by Michael Wonder on 10 Feb 2024
Lykos Therapeutics announces FDA acceptance and priority review of new drug application for MDMA assisted therapy for PTSD
9 February 2024 - PDUFA date is 11 August 2024. ...
Posted by Michael Wonder on 09 Feb 2024
Johnson & Johnson's nipocalimab granted US FDA breakthrough therapy designation for the treatment of individuals at high risk for severe haemolytic disease of the foetus and newborn
9 February 2024 - Breakthrough therapy designation for nipocalimab based on results from the Phase 2 UNITY clinical trial for haemolytic ...
Posted by Michael Wonder on 09 Feb 2024
Amneal announces complete response resubmission for IPX203 new drug application
8 February 2024 - Amneal Pharmaceuticals today announced that it has provided a complete response resubmission to the US FDA ...
Posted by Michael Wonder on 08 Feb 2024
Eplontersen granted US FDA fast track designation for patients with transthyretin-mediated amyloid cardiomyopathy
8 February 2024 - Ionis Pharmaceuticals announced today that the US FDA has granted fast track designation to Ionis and ...
Posted by Michael Wonder on 07 Feb 2024
Bristol Myers Squibb announces acceptance of US and EU regulatory filings for neo-adjuvant Opdivo (nivolumab) and chemotherapy followed by surgery and adjuvant Opdivo in resectable non-small cell lung cancer
7 February 2024 - Applications based on results from CheckMate-77T, the company’s second positive Phase 3 randomised trial with an immunotherapy-based ...
Posted by Michael Wonder on 07 Feb 2024
FDA and EMA launch parallel scientific advice pilot program for complex generics
7 February 2024 - CDER’s Office of Generic Drugs and the EMA launched a voluntary pilot program to facilitate concurrent discussions ...
Posted by Michael Wonder on 07 Feb 2024
FDA grants latozinemab breakthrough therapy designation for frontotemporal dementia due to a progranulin gene mutation
7 February 2024 - Latozinemab is the most advanced progranulin-elevating candidate in development for frontotemporal dementia with a progranulin gene mutation ...
Posted by Michael Wonder on 07 Feb 2024
GSK’s RSV vaccine, Arexvy, accepted under priority review in US for the prevention of RSV disease in adults aged 50-59 at increased risk
6 February 2024 - Application supported by positive results of a Phase 3 trial showing immune response and acceptable tolerability profile ...
Posted by Michael Wonder on 06 Feb 2024
Arvinas and Pfizer’s vepdegestrant (ARV-471) receives FDA fast track designation for the treatment of patients with ER positive/HER2 negative metastatic breast cancer
6 February 2024 - Vepdegestrant is an investigational PROteolysis Targeting Chimera (PROTAC) protein degrader designed to target and degrade the ...
Posted by Michael Wonder on 06 Feb 2024
BridgeBio Pharma announces US FDA acceptance of new drug application for acoramidis for the treatment of patients with transthyretin amyloid cardiomyopathy
5 February 2024 - Accepted with Prescription Drug User Fee Act action date of 29 November 2024; the FDA not currently ...
Posted by Michael Wonder on 06 Feb 2024
Valneva announces sale of priority review voucher for $103 million
5 February 2024 - Valneva today announced it sold the priority review voucher it received from the US FDA for ...
Posted by Michael Wonder on 05 Feb 2024
Ultimovacs receives FDA fast track designation for UV1 cancer vaccine for the treatment of patients with unresectable mesothelioma
5 February 2024 - The designation was granted by the US FDA based on results from the randomised Phase II clinical ...
Posted by Michael Wonder on 04 Feb 2024
Addressing the challenge of common chronic diseases — a view from the FDA
3 February 2024 - Of the 10 most common causes of death in the United States, 7 are chronic diseases: ...