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RSS FeedPosted by Michael Wonder on 15 Feb 2024
Dermavant submits supplemental new drug application to FDA for Vtama (tapinarof) 1% cream for the treatment of atopic dermatitis in adults and children 2 years of age and older
14 February 2024 - sNDA is supported by positive data from the Phase 3 ADORING 1 and ADORING 2 pivotal trials ...
Posted by Michael Wonder on 14 Feb 2024
Galderma announces regulatory filing acceptance for nemolizumab in prurigo nodularis and atopic dermatitis in the US and EU
14 February 2024 - Nemolizumab was granted US FDA priority review for prurigo nodularis. ...
Posted by Michael Wonder on 14 Feb 2024
FDA approves first medication to treat severe frostbite
14 February 2024 - The US FDA approved Aurlumyn (iloprost) injection to treat severe frostbite in adults to reduce the risk ...
Posted by Michael Wonder on 14 Feb 2024
US FDA accepts for priority review Bristol Myers Squibb’s application for Augtyro (repotrectinib) for the treatment of patients with NTRK positive locally advanced or metastatic solid tumours
14 February 2024 - The US FDA assigned a target action date of 15 June 2024. ...
Posted by Michael Wonder on 13 Feb 2024
FDA approves irinotecan liposome for first-line treatment of metastatic pancreatic adenocarcinoma
13 February 2024 - Today, the FDA approved irinotecan liposome (Onivyde, Ipsen) with oxaliplatin, fluorouracil, and leucovorin, for the first-line ...
Posted by Michael Wonder on 13 Feb 2024
Edgewise receives US FDA fast track designation for EDG-5506 for the treatment of Duchenne muscular dystrophy
13 February 2024 - Edgewise Therapeutics today announced that the US FDA has granted fast track designation for EDG-5506 for the ...
Posted by Michael Wonder on 13 Feb 2024
The threat of fungal infections is growing. Why is it so hard to make new drugs?
11 February 2024 - Last summer, the FDA denied an application for a new anti-fungal drug called olorofim, sending it back ...
Posted by Michael Wonder on 12 Feb 2024
RadioMedix and Orano Med receive FDA breakthrough therapy designation for AlphaMedix in gastro-enteropancreatic neuroendocrine tumours
12 February 2024 - First targeted alfa therapy to receive a breakthrough therapy designation. ...
Posted by Michael Wonder on 12 Feb 2024
BioXcel Therapeutics receives FDA fast track designation for BXCL701 for treatment of small cell neuroendocrine prostate cancer
12 February 2024 - BXCL701 is an investigational, oral innate immune activator designed to inflame the tumour microenvironment and augment CPI ...
Posted by Michael Wonder on 12 Feb 2024
GSK receives US FDA fast track designation for bepirovirsen in chronic hepatitis B
12 February 2024 - Designation underscores the unmet need for medicines that can achieve functional cure in patients with chronic ...
Posted by Michael Wonder on 12 Feb 2024
CymaBay announces FDA acceptance of NDA and priority review for seladelpar for the treatment of primary biliary cholangitis
12 February 2024 - FDA has granted priority review with a target PDUFA date of 14 August 2024. ...
Posted by Michael Wonder on 12 Feb 2024
FDA accepts Xspray Pharma’s NDA resubmission for Dasynoc
12 February 2024 - The US FDA has accepted the resubmission of Xspray Pharma’s new drug application for Dasynoc, following ...
Posted 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
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 ...