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RSS FeedPosted by Michael Wonder on 03 Apr 2024
FDA approves new antibiotic for three different uses
3 April 2024 - Today, the US FDA approved Zevtera (ceftobiprole medocaril sodium for injection) for the treatment of adults with ...
Posted by Michael Wonder on 03 Apr 2024
RemeGen's telitacicept (RC18) granted fast track designation by US FDA for treatment of primary Sjögren's syndrome
2 April 2024 - RemeGen has obtained fast track designation by the US FDA recently for its innovative BLyS/APRIL dual-target ...
Posted by Michael Wonder on 03 Apr 2024
Agenda for the July 2024 PBAC meeting
3 April 2024 - The agenda for the July 2024 PBAC meeting is now available. ...
Posted by Michael Wonder on 03 Apr 2024
Zanidatamab biologics license application for previously treated HER2 positive metastatic biliary tract cancer completed
2 April 2024 - Zymeworks is pleased to announce, along with our partners Jazz Pharmaceuticals, completion of the rolling submission of ...
Posted by Michael Wonder on 03 Apr 2024
Dostarlimab in combination with platinum-based chemotherapy for the treatment of patients with advanced or recurrent, high microsatellite instability or mismatch repair deficiency endometrial cancer
3 April 2024 - NICE has published final evidence-based recommendations on the use of dostarlimab (Jemperli) in combination with platinum-based ...
Posted by Michael Wonder on 03 Apr 2024
European Commission expands approval of Bristol Myers Squibb’s Reblozyl (luspatercept) to include first-line treatment of transfusion-dependent anaemia in adults with lower-risk myelodysplastic syndromes
2 April 2024 - Approval of Reblozyl is based on head-to-head, pivotal Phase 3 COMMANDS study, in which Reblozyl nearly doubled ...
Posted by Michael Wonder on 02 Apr 2024
TME Pharma receives US FDA fast track designation for lead asset NOX-A12 in brain cancer
2 April 2024 - Fast track designation for NOX-A12 follows recently announced FDA clearance of investigational new drug application for Phase ...
Posted by Michael Wonder on 02 Apr 2024
Polatuzumab vedotin in untreated diffuse large B-cell lymphoma: one step forward, two steps back
2 April 2024 - Roche designed its trial for both approval and health technology assessments but the analyses planned for ...
Posted by Michael Wonder on 02 Apr 2024
Joe Biden’s assault on the $900 child eczema cream
2 April 2024 - What the Inflation Reduction Act means for the cost of health care. ...
Posted by Michael Wonder on 02 Apr 2024
Mirum Pharmaceuticals’ Livmarli (maralixibat oral solution) receives positive reimbursement recommendation by Canada’s CADTH for patients with cholestatic pruritus in Alagille syndrome
2 April 2024 - Positive HTA recommendation for reimbursement signifies an important milestone towards public funding to treat eligible patients with ...
Posted by Michael Wonder on 02 Apr 2024
Cancer experts urge PHARMAC to fast-track 'life-saving' Keytruda
2 April 2024 - Breast cancer experts have urged PHARMAC to fast-track the drug Keytruda, for Kiwis with an aggressive ...
Posted by Michael Wonder on 02 Apr 2024
Datopotamab deruxtecan biologics license application accepted in the US for patients with previously treated metastatic HR positive, HER2 negative breast cancer
2 April 2024 - Application based on results from the TROPION-Breast01 Phase 3 trial. ...
Posted by Michael Wonder on 02 Apr 2024
Vamorolone for the treatment of patients with Duchenne muscular dystrophy
28 March 2024 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 02 Apr 2024
BMS’ oral plaque psoriasis drug Sotyktu gets reimbursement starting April
1 April 2024 - Starting this month, Sotyktu (deucravacitinib), an oral treatment for moderate to severe plaque psoriasis in adults, ...
Posted by Michael Wonder on 02 Apr 2024
Relugolix–estradiol–norethisterone acetate for the treatment of patients with pain associated with endometriosis
28 March 2024 - The Department of Health and Social Care has asked the NICE to produce guidance on the ...