Blog
RSS FeedPosted by Michael Wonder on 20 Mar 2023
Arrowhead receives FDA fast track designation for ARO-APOC3
20 March 2023 - Arrowhead Pharmaceuticals today announced the US FDA has granted fast track designation to ARO-APOC3 for reducing ...
Posted by Michael Wonder on 19 Mar 2023
Deciphera Pharmaceuticals announces FDA grants breakthrough therapy designation for Qinlock in second-line GIST patients with mutations in KIT exon 11 and 17/18
14 March 2023 - Breakthrough therapy designation is based on results from ctDNA analysis of INTRIGUE Phase 3 clinical trial demonstrating ...
Posted by Michael Wonder on 19 Mar 2023
Prestige Biopharma's pancreatic cancer drug candidate put on FDA fast track
17 March 2023 - Prestige Biopharma said on Thursday that its new pancreatic cancer antibody drug candidate, PBP1510, (ulenistamab), was ...
Posted by Michael Wonder on 17 Mar 2023
FDA approves dabrafenib with trametinib for paediatric patients with low grade glioma with a BRAF V600E mutation
16 March 2023 - Today, the FDA approved dabrafenib (Tafinlar, Novartis) with trametinib (Mekinist, Novartis) for paediatric patients 1 year ...
Posted by Michael Wonder on 16 Mar 2023
Ipsen receives new FDA PDUFA date for investigational palovarotene for the treatment of people with FOP
16 March 2023 - Ipsen today announced that the US FDA PDUFA goal date, for the resubmitted new drug application for ...
Posted by Michael Wonder on 15 Mar 2023
EMA-FDA parallel scientific advice program has ‘limited’ uptake
14 March 2023 - A review of the last five years of the parallel scientific advice program between the FDA ...
Posted by Michael Wonder on 11 Mar 2023
Maxigesic Rapid tablets gain US FDA approval
10 March 2023 - AFT Pharmaceuticals today announces the US FDA has approved a rapid release tablet form of Maxigesic ...
Posted by Michael Wonder on 11 Mar 2023
Acadia Pharmaceuticals announces US FDA approval of Daybue (trofinetide) for the treatment of Rett syndrome in adult and paediatric patients two years of age and older
10 March 2023 - Company expects Daybue to be available by the end of April 2023. ...
Posted by Michael Wonder on 10 Mar 2023
Pfizer’s Zavzpret (zavegepant) migraine nasal spray receives FDA approval
10 March 2023 - Zavzpret is the first and only calcitonin gene-related peptide receptor antagonist nasal spray for the acute treatment ...
Posted by Michael Wonder on 10 Mar 2023
Will NZ neurological drug Trofinetide for Rett syndrome get US FDA approval and make history?
10 March 2023 - Kiwi scientists may be about to make New Zealand history, with a breakthrough treatment on the ...
Posted by Michael Wonder on 08 Mar 2023
Preterm birth drug withdrawn after 12 years
7 March 2023 - The FDA seemed poised to rescind approval of Makena, after studies over time indicated the treatment did ...
Posted by Michael Wonder on 08 Mar 2023
Amphastar Pharmaceuticals receives FDA approval for naloxone hydrochloride nasal spray 4 mg
8 March 2023 - Amphastar Pharmaceuticals announced that the US FDA has granted approval of its new drug application for ...
Posted by Michael Wonder on 08 Mar 2023
US FDA accepts supplemental new drug application for Jardiance for children 10 years and older with type 2 diabetes
8 March 2023 - The application is based on phase III results from the DINAMO trial showing Jardiance (empagliflozin) tablets significantly ...
Posted by Michael Wonder on 08 Mar 2023
FDA accepts Novan’s NDA for berdazimer 10.3% topical gel for the treatment of molluscum contagiosum
7 March 2023 - FDA completes filing review of application with no filing issues identified. ...
Posted by Michael Wonder on 08 Mar 2023
FDA accepts BioMarin's supplemental new drug application to expand use of Voxzogo (vosoritide) for injection to treat children with achondroplasia under the age of 5
7 March 2023 - FDA set PDUFA target action date of 21 October 2023. ...