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RSS FeedPosted by Michael Wonder on 18 Jul 2025
European Commission grants conditional approval of Ezmekly
18 July 2025 - Ezmekly is the first and only therapy to receive marketing authorisation in the EU for both adults ...
Posted by Michael Wonder on 18 Jul 2025
Genentech provides update on supplemental biologics license application for Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma
18 July 2025 - Genentech announced today that the US FDA issued a complete response letter for Genentech’s supplemental biologics ...
Posted by Michael Wonder on 17 Jul 2025
US FDA approves GSK’s Shingrix in a pre-filled syringe presentation
17 July 2025 - Pre-filled syringe presentation offers a convenient administration option to health care professionals. ...
Posted by Michael Wonder on 16 Jul 2025
SMC - July 2025 decisions
7 July 2025 - The SMC which advises on newly licensed medicines for use by NHSScotland, has today published advice ...
Posted by Michael Wonder on 16 Jul 2025
MHRA approves sebetralstat (Ekterly) to treat hereditary angioedema attacks in patients aged 12 and over
15 July 2025 - The MHRA has today approved sebetralstat (Ekterly) for the treatment of hereditary angioedema attacks in adults and ...
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
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
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
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 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 ...
Posted by Michael Wonder on 13 Jul 2025
European Commission approves Tevimbra in combination with chemotherapy as a first-line treatment for nasopharyngeal carcinoma
10 July 2025 - New indication based on results of RATIONALE-309 study demonstrating statistically significant improvement in progression-free survival. ...
Posted by Michael Wonder on 13 Jul 2025
Ultragenyx receives complete response letter from FDA for UX111 AAV gene therapy to treat Sanfilippo syndrome type A
11 July 2025 - complete response letter cited specific chemistry, manufacturing and controls related observations that are resolvable. ...
Posted by Michael Wonder on 11 Jul 2025
Swissmedic approves Ifinwil (eflornithine) for children diagnosed with high-risk neuroblastoma
8 July 2025 - Norgine is pleased to announce that Swissmedic has approved the registration of Ifinwil (eflornithine) as monotherapy ...