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RSS FeedPosted by Michael Wonder on 12 Mar 2024
Johnson & Johnson submits supplemental biologics license application to US FDA seeking approval of Tremfya (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis
11 March 2024 - Submission is supported by data from the Phase 3 QUASAR program, which showed a significantly greater percentage ...
Posted by Michael Wonder on 12 Mar 2024
Travere Therapeutics submits supplemental new drug application to the US FDA seeking full approval of Filspari (sparsentan) for the treatment of IgA nephropathy
11 March 2024 - Submission is based on 2 year confirmatory results from the Phase 3 PROTECT study in which Filspari ...
Posted by Michael Wonder on 12 Mar 2024
Viatris and Mapi Pharma statement regarding new drug application for glatiramer acetate depot
11 March 2024 - Viatris has been informed that Mapi Pharma has received a complete response letter regarding the new drug ...
Posted by Michael Wonder on 11 Mar 2024
Celltrion USA completes submission of biologics license application to US FDA for CT-P39, an interchangeable biosimilar candidate of Xolair (omalizumab)
10 March 2024 - The BLA for CT-P39 was based on totality of evidence including results from Phase III data ...
Posted by Michael Wonder on 07 Mar 2024
Johnson & Johnson submits application to the EMA for Darzalex (daratumumab)-based quadruplet therapy for the treatment of patients with transplant-eligible, newly diagnosed multiple myeloma
6 March 2024 - Submission supported by data from Phase 3 PERSEUS study, which showed the daratumumab subcutaneous formulation-based regimen significantly ...
Posted 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
New treatment option available today for womb cancer
5 March 2024 - A new treatment option given with chemotherapy is recommended for some types of advanced or recurrent ...
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. ...