Blog
RSS FeedPosted by Michael Wonder on 08 Mar 2025
Vertex announces UK MHRA approval of Alyftrek (deutivacaftor/tezacaftor/vanzacaftor), a once daily next in class CFTR modulator for the treatment of cystic fibrosis
7 March 2025 - In head to head clinical trials, deutivacaftor/tezacaftor/vanzacaftor was non-inferior on ppFEV1 and further decreased sweat chloride ...
Posted by Michael Wonder on 03 Mar 2025
Vertex receives CHMP positive opinion for expanded label for Kaftrio in combination with ivacaftor for people with cystic fibrosis to include rare mutations
28 February 2025 - If approved, approximately 4,000 people with cystic fibrosis in the European Union will be eligible for ...
Posted by Michael Wonder on 07 Feb 2025
US FDA approves Emblaveo (aztreonam and avibactam) for the treatment of adults with complicated intra-abdominal infections with limited or no treatment options
7 February 2025 - Emblaveo is the first and only monobactam/β-lactamase inhibitor combination antibiotic therapy approved by the US FDA to ...
Posted by Michael Wonder on 31 Jan 2025
Axsome Therapeutics announces FDA approval of Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults
30 January 2025 - A single oral dose of Symbravo provided rapid migraine pain freedom and return to normal functioning within ...
Posted by Michael Wonder on 22 Dec 2024
Vertex announces US FDA approval of Alyftrek, a once daily next in class CFTR modulator for the treatment of cystic fibrosis
20 December 2024 - In head to head clinical trials, Alyftrek was non-inferior on ppFEV1 and further decreased sweat chloride ...
Posted by Michael Wonder on 22 Dec 2024
Vertex announces US FDA approval for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to include additional non-F508del Trikafta responsive variants
20 December 2024 - Approximately 300 more people with cystic fibrosis in the US are now eligible for a medicine ...
Posted by Michael Wonder on 14 Dec 2024
Roche Canada and the pan-Canadian Pharmaceutical Alliance successfully complete negotiations for Tecentriq SC (atezolizumab solution for subcutaneous injection)
13 December 2024 - Roche Canada today announced that it successfully completed negotiations with the pan-Canadian Pharmaceutical Alliance for Tecentriq ...
Posted by Michael Wonder on 06 Dec 2024
Esperion announces new drug submissions in Canada for Nexletol (bempedoic acid) and Nexlizet (bempedoic acid and ezetimibe) treatments to reduce LDL-cholesterol and cardiovascular risk
2 December 2024 - Esperion today announced that it has filed new drug submissions to Health Canada for Nexletol and Nexlizet, ...
Posted by Michael Wonder on 18 Oct 2024
US FDA approves Vyalev (foscarbidopa and foslevodopa) for adults living with advanced Parkinson's disease
17 October 2024 - Adults treated with Vyalev reported superior improvement in "on" time without troublesome dyskinesia, compared to oral immediate-release ...
Posted by Michael Wonder on 04 Oct 2024
Netarsudil mesylate with latanoprost for the treatment of patients with primary open-angle glaucoma or ocular hypertension
2 October 2024 - NiCE has published final evidence-based recommendations on the use of netarsudil mesylate with latanoprost (Roclanda) for ...
Posted by Michael Wonder on 02 Oct 2024
Securing supply of PrEP
1 October 2024 - The Australian Government is ensuring thousands of Australians, with or at risk of contracting HIV, are ...
Posted by Michael Wonder on 29 Sep 2024
Vertex announces Health Canada acceptance of new drug submission for vanzacaftor/tezacaftor/deutivacaftor, a next in class triple combination treatment for cystic fibrosis
26 September 2024 - Vertex Pharmaceuticals today announced that Health Canada has accepted for review its new drug submission for ...
Posted by Michael Wonder on 27 Sep 2024
FDA approves drug with new mechanism of action for treatment of schizophrenia
26 September 2024 - Today, the US FDA approved Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment ...
Posted by Michael Wonder on 12 Sep 2024
Health Canada approves Cabtreo (clindamycin phosphate, adapalene and benzoyl peroxide) triple combination topical treatment for acne vulgaris in patients 12 years of age and older
11 September 2024 - Bausch Health today announced the approval by Health Canada of Cabtreo (clindamycin phosphate, adapalene and benzoyl ...
Posted by Michael Wonder on 05 Sep 2024
Breakthrough therapy designation for Sanbexin sublingual tablets granted by the US FDA
5 September 2024 - On 2 September 2024, Simcere Pharmaceuticals announced that Sanbexin sublingual tablets (edaravone and dexborneol sublingual tablets), an ...