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RSS FeedPosted by Michael Wonder on 04 Jan 2023
Janssen submits marketing authorisation application to the European Medicines Agency seeking approval of talquetamab for the treatment of patients with relapsed or refractory multiple myeloma
3 January 2023 - Janssen today announced the submission of a marketing authorisation application to the EMA seeking approval of ...
Posted by Michael Wonder on 04 Jan 2023
European Medicines Agency validates marketing authorisation application for Trodelvy (sacituzumab govitecan-hziy) for pre-treated HR+/HER2- metastatic breast cancer
3 January 2023 - Application based on statistically significant and clinically meaningful overall survival and progression-free survival results from the Phase ...
Posted by Michael Wonder on 04 Jan 2023
European Medicines Agency validates application for extension of indication for Vozogo (vosoritide) for injection to treat children with achondroplasia under the age of 2
4 January 2023 - BioMarin submits supplemental new drug application to US FDA to expand label to treat children with achondroplasia ...
Posted by Michael Wonder on 30 Dec 2022
Heron Therapeutics announces filing of an efficacy supplement for Zynrelef and provision in newly passed congressional bill anticipated to provide separate reimbursement outside of the packaged surgical payment for Zynrelef
29 December 2022 - Supplemental new drug application submitted requesting expansion of indication to broadly cover soft tissue and orthopaedic surgical ...
Posted by Michael Wonder on 29 Dec 2022
US FDA accepts for review the biologics license application for Pfizer’s investigational pentavalent meningococcal vaccine candidate (MenABCWY) in adolescents
28 December 2022 - Pfizer today announced that the US FDA accepted for review a biologics license application for its investigational ...
Posted by Michael Wonder on 29 Dec 2022
TG Therapeutics announces FDA approval of Briumvi (ublituximab-xiiy)
28 December 2022 - US commercial launch expected Q1, 2023. ...
Posted by Michael Wonder on 28 Dec 2022
EOFlow submits application to the US FDA for its wearable insulin pump 'EOPatch'
27 December 2022 - Plans to finalise its US distribution strategy in 2023. ...
Posted by Michael Wonder on 27 Dec 2022
SpringWorks Therapeutics completes submission of new drug application to the FDA for nirogacestat for the treatment of adults with desmoid tumours
27 December 2022 - SpringWorks Therapeutics announced today that the Company has completed the submission of a new drug application ...
Posted by Michael Wonder on 27 Dec 2022
Harm Reduction Therapeutics' new drug application for RiVive over the counter naloxone nasal spray accepted and granted priority review by FDA
26 December 2022 - Low cost, over the counter naloxone nasal spray advances to FDA review. Approval would increase access ...
Posted by Michael Wonder on 26 Dec 2022
Junshi Biosciences and Coherus share update on the FDA review of the biologics license application for toripalimab as treatment for recurrent or metastatic nasopharyngeal carcinoma
25 December 2022 - FDA has been unable to travel to China to conduct the required site inspection resulting in delayed ...
Posted by Michael Wonder on 24 Dec 2022
Intercept resubmits new drug application to US FDA for obeticholic acid in patients with liver fibrosis due to NASH
23 December 2022 - New drug application supported by robust NASH clinical development program, including two positive interim analyses from the ...
Posted by Michael Wonder on 24 Dec 2022
Celltrion USA announces submission of the biologics license application of novel subcutaneous formulation of CT-P13 to US FDA
22 December 2022 - CT-P13 SC is a novel subcutaneous formulation of infliximab. ...
Posted by Michael Wonder on 24 Dec 2022
Ipsen receives complete response letter for palovarotene, an investigational treatment for fibrodysplasia ossificans progressiva
23 December 2022 - The letter is related to the US FDA’s previous request for additional information on palovarotene clinical trial ...
Posted by Michael Wonder on 24 Dec 2022
Adaptimmune announces initiation of biologics license application submission for afami-cel, its first generation engineered TCR T-cell therapy targeting MAGE-A4, for the treatment of synovial sarcoma
23 December 2022 - Afami-cel has the potential to be the first approved engineered TCR T-cell therapy for a solid tumour. ...
Posted by Michael Wonder on 24 Dec 2022
Neurocrine Biosciences announces US FDA accepts supplemental new drug application for valbenazine as a treatment for chorea associated with Huntington disease
22 December 2022 - PDUFA target action date set for 20 August 2023. ...