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RSS FeedPosted by Michael Wonder on 06 Mar 2024
Vanda Pharmaceuticals announces FDA update for supplemental NDA for Hetlioz in the treatment of insomnia
6 March 2024 - Vanda Pharmaceuticals today announced that on 4 March 2024, it received a complete response letter from ...
Posted by Michael Wonder on 06 Mar 2024
Camurus announces FDA acceptance of NDA submission for Oclaiz for treatment of acromegaly
5 March 2024 - PDUFA set to 21 October 2024. ...
Posted by Michael Wonder on 06 Mar 2024
CymaBay announces EMA accepts for review the marketing authorisation application for seladelpar for the treatment of primary biliary cholangitis
5 March 2024 - MAA validation follows recent applications for seladelpar to the UK MHRA and US FDA. ...
Posted by Michael Wonder on 06 Mar 2024
Madrigal Pharmaceuticals announces EMA validation of its marketing authorisation application for resmetirom for the treatment of NASH/MASH with liver fibrosis
5 March 2024 - MAA submission is supported by positive results from MAESTRO-NASH, the only Phase 3 trial in NASH to ...
Posted by Michael Wonder on 05 Mar 2024
AB Science today announces that Health Canada has issued a screening acceptance letter for the application of masitinib in the treatment of amyotrophic lateral sclerosis
9 May 2023 - AB Science today announces that Health Canada has issued a screening acceptance letter for ...
Posted by Michael Wonder on 05 Mar 2024
Zevra Therapeutics provides FDA update on the PDUFA action date for arimoclomol as a treatment for Niemann-Pick disease type C
4 March 2024 - The new PDUFA action date set by the FDA is 21 September 2024. ...
Posted by Michael Wonder on 04 Mar 2024
SpringWorks Therapeutics initiates rolling submission of new drug application to the FDA for mirdametinib for the treatment of children and adults with NF1-PN
4 March 2024 - SpringWorks Therapeutics announced today that the Company has initiated a rolling submission of a new drug application ...
Posted by Michael Wonder on 04 Mar 2024
Two datopotamab deruxtecan applications validated in the EU for patients with advanced non-squamous non-small cell lung cancer or HR positive, HER2 negative breast cancer
4 March 2024 - Parallel applications based on TROPION-Lung01 and TROPION-Breast01 Phase 3 trial results demonstrating Daiichi Sankyo and AstraZeneca’s ...
Posted by Michael Wonder on 01 Mar 2024
Intercept announces FDA acceptance of supplemental new drug application for Ocaliva (obeticholic acid) for the treatment of PBC
29 February 2024 - FDA has assigned a PDUFA target action date of 15 October 2024. ...
Posted by Michael Wonder on 01 Mar 2024
SpringWorks Therapeutics announces EMA validation for marketing authorisation application of nirogacestat for the treatment of adults with desmoid tumours
29 February 2024 - Application based on Phase 3 DeFi trial in which nirogacestat significantly improved progression-free survival and objective response ...
Posted by Michael Wonder on 28 Feb 2024
Applied Therapeutics announces FDA acceptance and priority review of new drug application for govorestat for the treatment of classic galactosaemia
28 February 2024 - PDUFA target action date of 28 August 2024. ...
Posted by Michael Wonder on 28 Feb 2024
Incyte announces US FDA grants priority review for axatilimab for the treatment of chronic graft versus host disease
27 February 2024 - Priority review acceptance based on positive results of AGAVE-201 study. ...
Posted by Michael Wonder on 27 Feb 2024
Theratechnologies receives refusal to file letter for Trogarzo intramuscular method of administration sBLA from FDA
27 February 2024 - Theratechnologies today announced that the US FDA has issued a refusal to file letter regarding the Company’s ...
Posted by Michael Wonder on 27 Feb 2024
BeiGene’s biologics license application for Tevimbra (tislelizumab) for first-line gastric or gastro-oesophageal junction cancers accepted by FDA
27 February 2024 - Application based on results from global Phase 3 RATIONALE-305 trial demonstrating Tevimbra plus chemotherapy significantly improved overall ...
Posted by Michael Wonder on 27 Feb 2024
Minerva Neurosciences receives complete response letter from FDA for new drug application for roluperidone for the treatment of negative symptoms in patients with schizophrenia
27 February 2024 - Minerva Neurosciences announced today that the US FDA has issued a complete response letter to the ...