Blog
RSS FeedPosted by Michael Wonder on 09 Apr 2024
ViiV Healthcare announces US FDA approval of Dovato (dolutegravir/lamivudine) for adolescents living with HIV
8 April 2024 - Dovato is now the first and only oral, two drug, single-tablet regimen available for people aged 12 ...
Posted by Michael Wonder on 25 Mar 2024
US FDA approves Opsynvi (macitentan and tadalafil) as the first and only once daily single tablet combination therapy for patients with pulmonary arterial hypertension
22 March 2024 - Approval is based on the results from the pivotal Phase 3 A DUE study, which met ...
Posted by Michael Wonder on 24 Feb 2024
Venatorx and Melinta provide update on status of US new drug application for cefepime-taniborbactam
23 February 2024 - No clinical safety or efficacy issues identified. ...
Posted by Michael Wonder on 22 Feb 2024
TGA approves new medication for treatment of endometriosis symptoms
23 February 2024 - Australian drug regulator gives company green light for tablet – although it won’t be subsidised by Pharmaceutical ...
Posted by Michael Wonder on 10 Feb 2024
AbbVie's Vyalev (foslevodopa/foscarbidopa solution) available for the treatment of advanced Parkinson's disease in Canada
8 February 2024 - In clinical trials, patients taking Vyalev achieved the primary endpoint of a reduction in motor fluctuations ...
Posted by Michael Wonder on 03 Dec 2023
Duchesnay is seeking Health Canada approval for a segesterone acetate/ethinyl estradiol contraceptive vaginal system, a new option for women
30 November 2023 - Duchesnay has recently filed a new drug submission to Health Canada for its segesterone acetate/ethinyl estradiol slow ...
Posted by Michael Wonder on 29 Nov 2023
Karuna Therapeutics announces US FDA accepts new drug application for KarXT for the treatment of schizophrenia
29 November 2023 - PDUFA action date is 26 September 2024. ...
Posted by Michael Wonder on 25 Nov 2023
Vertex announces EMA validation for marketing authorisation application extension for Kaftrio in combination with ivacaftor to include people with cystic fibrosis and responsive rare mutations
24 November 2023 - Application to add ~200 non-F508del CFTR mutations to the Kaftrio license. ...
Posted by Michael Wonder on 23 Nov 2023
European Commission approves Kaftrio in combination with ivacaftor for the treatment of children with cystic fibrosis ages 2 through 5
23 November 2023 - More than 1,200 children are newly eligible for a medicine that could treat the underlying cause ...
Posted by Michael Wonder on 08 Nov 2023
Zydus receives US FDA approval for Zituvimet to treat adult patients with type 2 diabetes mellitus
6 November 2023 - The company received final approval from the US FDA for its new drug application for Zituvimet ...
Posted by Michael Wonder on 03 Nov 2023
EC approves Ryeqo for the symptomatic treatment of endometriosis
2 November 2023 - Gedeon Richter together with Sumitomo today announce that the European Commission has granted approval of a type ...
Posted by Michael Wonder on 23 Oct 2023
FDA approves Cabtreo (clindamycin phosphate, adapalene and benzoyl peroxide) topical gel for the treatment of acne vulgaris in patients twelve years of age and older
20 October 2023 - First and only FDA approved fixed dose, triple combination topical treatment. ...
Posted by Michael Wonder on 20 Oct 2023
Sumitomo Pharma and Pfizer in Canada receive Health Canada approval for Myfembree
19 October 2023 - Sumitomo Pharma Canada and Pfizer Canada today announced that Health Canada has granted a notice of compliance ...
Posted by Michael Wonder on 14 Oct 2023
Amylyx Pharmaceuticals receives negative CHMP opinion on its marketing authorisation application for AMX0035 for the treatment of ALS in the European Union following re-examination process
13 October 2023 - Final decision from the European Commission expected by the end of 2023. ...
Posted by Michael Wonder on 16 Sep 2023
Vertex receives CHMP positive opinion for Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor for children with cystic fibrosis ages 2 through 5
15 September 2023 - If approved, more than 1,200 children would be newly eligible for a medicine that could treat ...