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RSS FeedPosted by Michael Wonder on 03 Dec 2022
Orchard Therapeutics announces Swissmedic validation of the marketing authorisation application for Libmeldy (atidarsagene autotemcel)
1 December 2022 - Orchard Therapeutics today announced its marketing authorisation application for Libmeldy (atidarsagene autotemcel) has been accepted for ...
Posted by Michael Wonder on 03 Dec 2022
European Medicines Agency accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis
2 December 2022 - Application includes data from key Phase 3 trials, including the pivotal MOMENTUM trial, which met all ...
Posted by Michael Wonder on 03 Dec 2022
EQRx announces acceptance of marketing authorisation application by the European Medicines Agency for aumolertinib in EGFR mutated non-small-cell lung cancer
2 December 2022 - Application is based on data from the pivotal Phase 3 AENEAS trial evaluating aumolertinib as first-line ...
Posted by Michael Wonder on 03 Dec 2022
COVID-19 vaccine safety report (1 December 2022)
1 December 2022 - To 27 November 2022, the TGA has received 709 reports which have been assessed as likely to ...
Posted by Michael Wonder on 02 Dec 2022
FDA approves olutasidenib for relapsed or refractory acute myeloid leukaemia with a susceptible IDH1 mutation
1 December 2022 - Today, the FDA approved olutasidenib (Rezlidhia) capsules for adult patients with relapsed or refractory acute myeloid ...
Posted by Michael Wonder on 02 Dec 2022
Y-mAbs announces complete response letter for omburtamab biologics license application
1 December 2022 - Y-mAbs Therapeutics today announced that the US FDA has issued a complete response letter for the ...
Posted by Michael Wonder on 01 Dec 2022
Citius Pharmaceuticals announces US FDA acceptance of biologics license application of denileukin diftitox for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma
1 December 2022 - PDUFA target action date is 28 September 2023. ...
Posted by Michael Wonder on 01 Dec 2022
FDA grants fast track designation to Nuvectis Pharma's NXP800 for the treatment of platinum-resistant, ARID1A mutated ovarian carcinoma
1 December 2022 - Nuvectis Pharma today announced that the US FDA has granted fast track designation to NXP800 for the ...
Posted by Michael Wonder on 01 Dec 2022
Scynexis announces FDA approval of second indication for Brexafemme (ibrexafungerp) for reduction in incidence of recurrent vulvovaginal candidiasis
1 December 2022 - Approval is based on pivotal Phase 3 CANDLE data demonstrating statistically significant superiority of ibrexafungerp over ...
Posted by Michael Wonder on 01 Dec 2022
Oncolytics Biotech receives FDA fast track designation for the treatment of advanced/metastatic pancreatic cancer
1 December 2022 - FDA fast rack designation granted after presentation at the SITC 37th Annual Meeting demonstrating 69% objective ...
Posted by Michael Wonder on 01 Dec 2022
Innoviva announces FDA acceptance and priority review of new drug application for sulbactam-durlobactam
30 November 2022 - Sulbactam-durlobactam is a targeted antibiotic that was specifically designed to treat serious infections caused by Acinetobacter baumannii, ...
Posted by Michael Wonder on 01 Dec 2022
FDA approves first faecal microbiota product
30 November 2022 - Today, the US FDA approved Rebyota, the first faecal microbiota product approved by the agency. ...
Posted by Michael Wonder on 30 Nov 2022
How CSL priced the world’s most expensive drug
1 December 2022 - When blood products giant CSL announced last week it had been given US regulatory approval for ...
Posted by Michael Wonder on 30 Nov 2022
Evkeeza (evinacumab-dgnb) sBLA for children with ultra rare inherited form of high cholesterol accepted for FDA priority review
30 November 2022 - If approved, Evkeeza would be the first and only treatment of its kind to help children ...
Posted by Michael Wonder on 30 Nov 2022
Swiss National Council votes to accept FDA approved medical devices
29 November 2022 - On November 28, the Swiss Parliament National Council voted to adapt its national laws, allowing Switzerland to ...