Blog
RSS FeedPosted by Michael Wonder on 28 Mar 2024
IntraBio announces US FDA accepts new dug application for IB1001 for the treatment of Niemann-Pick disease type C
26 March 2024 - PDUFA date set for 24 September 2024. ...
Posted by Michael Wonder on 31 Mar 2022
New drug application resubmission
31 March 2022 - NDA submission for Polarean’s hyperpolarised 129Xenon gas drug device combination product ...
Posted by Michael Wonder on 27 Feb 2019
Bayer completes rolling submission for darolutamide in U.S.
27 February 2019 - Bayer today announced the completion of the rolling submission of a new drug application for darolutamide to ...
Posted by Michael Wonder on 13 Nov 2017
Sunovion announces FDA acceptance for review of new drug application for dasotraline for the treatment of ADHD
10 November 2017 - Sunovion Pharmaceuticals today announced that the U.S. FDA has accepted for review the new drug application ...
Posted by Michael Wonder on 10 Nov 2017
FDA accepts Otsuka's resubmission to support a regulatory review of tolvaptan in the treatment of ADPKD
9 November 2017 - Tolvaptan has been studied in patients with autosomal dominant polycystic kidney disease in a clinical trial program ...
Posted by Michael Wonder on 08 Nov 2017
GSK submits US regulatory application for mepolizumab in eosinophilic chronic obstructive pulmonary disease
7 November 2017 - GlaxoSmithKline today announced the submission of a supplemental biologics license application to the United States FDA, ...
Posted by Michael Wonder on 05 Nov 2017
Trevena announces submission of new drug application to U.S. FDA for Olinvo (oliceridine injection)
2 November 2017 - Filing supported by positive Phase 3 APOLLO and ATHENA studies. ...
Posted by Michael Wonder on 22 Jun 2017
Seattle Genetics submits supplemental biologics license application to FDA for Adcetris (brentuximab vedotin) in cutaneous T cell lymphoma
20 June 2017 - Application based on clinical trial results from the Phase 3 ALCANZA and Phase 2 investigator sponsored ...
Posted by Michael Wonder on 20 Jun 2017
FDA grants fast track designation to Axovant's nelotanserin for visual hallucinations in dementia with Lewy bodies
19 June 2017 - Axovant Sciences today announced that the U.S. FDA has granted fast track designation to its investigational ...
Posted by Michael Wonder on 19 Jun 2017
FDA accepts Amgen's supplemental biologics license application to expand indication for Xgeva (denosumab) to include multiple myeloma patients
19 June 2017 - FDA sets PDUFA target action date of 3 February 2018. ...
Posted by Michael Wonder on 15 Jun 2017
FDA accepts Sandoz regulatory submission for a generic version of Advair Diskus
15 June 2017 - Sandoz believes its combination product will offer asthma and COPD patients same safety and efficacy as reference ...
Posted by Michael Wonder on 07 Jun 2017
Pfizer receives FDA fast track designation for tafimidis for transthyretin cardiomyopathy
6 June 2017 - Tafamidis, an investigational medicine for TTR-CM a rare, progressive and fatal disease, is currently in phase ...
Posted by Michael Wonder on 06 Jun 2017
BioCryst announces Rapivab paediatric sNDA acceptance
5 June 2017 - BioCryst Pharmaceuticals announced today that the U.S. FDA has accepted for review the supplemental new drug ...
Posted by Michael Wonder on 05 Jun 2017
Amgen submits regulatory applications for Repatha (evolocumab) cardiovascular outcomes data in US and Europe
5 June 2017 - Amgen today announced the submission of a supplemental biologics license application to the U.S. FDA and a ...
Posted by Michael Wonder on 04 Jun 2017
ViiV Healthcare submits regulatory applications for the first HIV maintenance regimen comprising only two medicines
1 June 2017 - Priority review voucher submitted in US with anticipated target action date of 6 months. ...