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RSS FeedPosted by Michael Wonder on 07 Jan 2023
US FDA accepts for priority review the supplemental biologics license application for Pfizer’s 20 valent pneumococcal conjugate vaccine in infants and children
6 January 2023 - If approved, the vaccine would provide the broadest serotype coverage of any pneumococcal conjugate vaccine in infants ...
Posted by Michael Wonder on 06 Jan 2023
UCB announces rozanolixizumab BLA for the treatment of generalised myasthenia gravis filed with US FDA and designated for priority review
6 January 2023 - Biologic license application designated priority review by FDA and seeks approval for rozanolixizumab for the treatment ...
Posted by Michael Wonder on 05 Jan 2023
Nirsevimab US regulatory submission accepted for the prevention of RSV lower respiratory tract disease in infants and children up to age 24 months
5 January 2023 - Submission supported by comprehensive clinical trial programme, which demonstrated protection against RSV disease through the RSV ...
Posted by Michael Wonder on 05 Jan 2023
Checkpoint Therapeutics submits biologics license application to FDA for cosibelimab as a treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma
4 January 2023 - Positive and clinically meaningful pivotal clinical results announced in 2022 in both metastatic and locally advanced indications. ...
Posted by Michael Wonder on 04 Jan 2023
Orasis Pharmaceuticals submits new drug application for investigational novel eye drop candidate, CSF-1, for the treatment of presbyopia
3 January 2023 - Phase 3 NEAR-1 and NEAR-2 clinical trials, involving over 600 patients, met primary and key secondary ...
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. ...