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RSS FeedPosted 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 04 Nov 2023
Elexacaftor with tezacaftor and ivacaftor, tezacaftor with ivacaftor and lumacaftor with ivacaftor for the treatment of patients with cystic fibrosis
3 November 2023 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
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
Pfizer to price Covid drug Paxlovid at $1,390 per course
18 October 2023 - Health insurance plans will likely pay much less than the nearly $1,400 list price for Paxlovid, ...
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 ...
Posted by Michael Wonder on 15 Aug 2023
Venatorx Pharmaceuticals announces FDA acceptance and priority review of new drug application for cefepime-taniborbactam to treat complicated urinary tract infections, including pyelonephritis, in adults
15 August 2023 - PDUFA action date set for 22 February 2024. ...
Posted by Michael Wonder on 11 Aug 2023
FDA approves niraparib and abiraterone acetate plus prednisone for BRCA mutated metastatic castration-resistant prostate cancer
11 August 2023 - Today, the FDA approved the fixed dose combination of niraparib and abiraterone acetate (Akeega, Janssen Biotech), ...
Posted by Michael Wonder on 02 Aug 2023
FDA approves trifluridine and tipiracil with bevacizumab for previously treated metastatic colorectal cancer
2 August 2023 - Today, the FDA approved trifluridine and tipiracil (Lonsurf, Taiho Oncology) with bevacizumab, for metastatic colorectal cancer ...
Posted by Michael Wonder on 27 Jul 2023
New Brunswick to publicly reimburse Albrioza for the treatment of ALS
24 July 2023 - New Brunswick lists Albrioza on its drug benefit formulary, becoming the fourth province to provide public ...
Posted by Michael Wonder on 27 Jul 2023
British Columbia to publicly reimburse Albrioza for the treatment of ALS
19 July 2023 - Amylyx Pharmaceuticals Canada announced today that the Company has entered into a Product Listing Agreement with British ...