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RSS FeedPosted by Michael Wonder on 15 Jul 2025
New cystic fibrosis drug fast tracked for NHS use
15 July 2025 - Some people with cystic fibrosis are set to benefit from a new once daily triple therapy treatment, ...
Posted by Michael Wonder on 15 Jul 2025
ICER publishes final evidence report on treatment for secondary progressive multiple sclerosis
15 July 2025 - Independent appraisal committee voted that current evidence is not adequate to demonstrate a net health benefit ...
Posted by Michael Wonder on 15 Jul 2025
Biocon Biologics expands diabetes portfolio with FDA approval of Kirsty, the first and only interchangeable rapid acting insulin aspart in the US
15 July 2025 - Biocon Biologics today announced that the US FDA has approved Kirsty (insulin aspart-xjhz), 100 units/mL as the ...
Posted by Michael Wonder on 15 Jul 2025
Regulatory and clinical outcomes of non-oncology accelerated approvals
14 July 2025 - The US FDA accelerated approval pathway expedites drug approvals based on changes to surrogate or intermediate measures ...
Posted by Michael Wonder on 15 Jul 2025
US FDA accepts application to review expanded use of GSK’s RSV vaccine, Arexvy, for adults 18-49 at increased risk
14 July 2025 - FDA decision anticipated H1, 2026 ...
Posted by Michael Wonder on 15 Jul 2025
Sun Pharma announces launch of Leqselvi (deuruxolitinib) in the US for the treatment of severe alopecia areata
14 July 2025 - Leqselvi now available for prescription in US nationwide, offering a new option for eligible patients ...
Posted by Michael Wonder on 15 Jul 2025
Vertex announces broad reimbursement agreement with NHS England for Alyftrek (deutivacaftor/tezacaftor/vanzacaftor) an innovative once daily CFTR modulator for the treatment of cystic fibrosis
14 July 2025 - All eligible people with cystic fibrosis in England can now benefit from this medicine - ...
Posted by Michael Wonder on 15 Jul 2025
Health Canada extends the approval of Evkeeza (evinacumab) to children as young as 6 months old with homozygous familial hypercholesterolaemia
14 July 2025 - Ultragenyx today announced that Health Canada has extended the approval of Evkeeza (evinacumab) as an adjunct to ...
Posted by Michael Wonder on 15 Jul 2025
Atara Biotherapeutics provides regulatory and business updates on tabelecleucel
14 July 2025 - Atara Biotherapeutics resubmits tabelecleucel biologics license application for treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease to ...
Posted by Michael Wonder on 15 Jul 2025
US FDA approves finerenone for new indication in patients with heart failure with left ventricular ejection fraction of ≥40%
14 July 2025 - New indication approval follows the US FDA’s priority review designation and is based on positive results from ...
Posted by Michael Wonder on 15 Jul 2025
FDA grants Zenith’s ZEN-3694 fast track status
14 July 2025 - Zenith Epigenetics is pleased to announce the designation of ZEN-3694 as a fast track product by the ...
Posted by Michael Wonder on 15 Jul 2025
Moderna receives full US FDA approval for COVID-19 vaccine, Spikevax, in children aged 6 months through 11 years at increased risk for COVID-19 disease
10 July 2025 - Spikevax is now approved for all adults aged 65 years and older, and individuals aged 6 ...
Posted by Michael Wonder on 14 Jul 2025
Astellas Korea renews bid to reimburse targeted gastric cancer drug Vyloy
11 July 2025 - Astellas Korea will reapply for health insurance coverage for its new drug Vyloy (zolbetuximab), a targeted ...
Posted by Michael Wonder on 13 Jul 2025
Delgocitinib for the treatment of patients with moderate to severe chronic hand eczema
8 July 2025 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 13 Jul 2025
Zanubrutinib for the treatment of patients with relapsed or refractory mantle cell lymphoma
10 July 2025 - NICE has published final evidence-based recommendations on the use of zanubrutinib for the treatment of adults ...