Blog
RSS FeedPosted by Michael Wonder on 16 Jul 2025
BeOne bets Tevimbra will beat rivals to PD-1 reimbursement in Korea
15 July 2025 - BeOne Medicines (formerly BeiGene) is doubling down on Korea’s immunotherapy market with an early access push ...
Posted by Michael Wonder on 16 Jul 2025
Corcept submits new drug application for relacorilant as a treatment for patients with platinum-resistant ovarian cancer
14 July 2025 - Corcept Therapeutics has submitted a new drug application to the US FDA for its proprietary, selective ...
Posted by Michael Wonder on 16 Jul 2025
Health Canada approves Lilly's Omvoh (mirikizumab) for Crohn's disease; new citrate-free formulation
15 July 2025 - Eli Lilly Canada announced today that Health Canada has approved Omvoh (mirikizumab) for Crohn's disease, which will ...
Posted by Michael Wonder on 15 Jul 2025
Egetis receives FDA breakthrough therapy designation for tiratricol for MCT8 deficiency
15 July 2025 - Egetis Therapeutics today announced that the US FDA has granted breakthrough therapy designation for tiratricol, as ...
Posted by Michael Wonder on 15 Jul 2025
Taxis Pharmaceuticals earns FDA QIDP designation for TXA14007, an investigational efflux pump inhibitor to combat antibiotic resistant pneumonia
15 July 2025 - Taxis Pharmaceuticals announced today that it has received an FDA qualified infectious disease product designation for TXA14007, ...
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
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
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
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
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 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 ...