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RSS FeedPosted by Michael Wonder on 14 May 2025
FDA approves belzutifan for pheochromocytoma or paraganglioma
14 May 2025 - Today, the FDA approved belzutifan (Welireg, Merck) for adult and paediatric patients 12 years and older ...
Posted by Michael Wonder on 14 May 2025
MHRA approves first UK treatment for congenital thrombotic thrombocytopenic purpura
12 May 2025 - The MHRA has today approved rADAMTS13 (Adzynma), the first UK treatment to treat congenital thrombotic thrombocytopenic purpura ...
Posted by Michael Wonder on 13 May 2025
SMC - May 2025 decisions
13 May 2025 - The SMC, which advises on newly licensed medicines for use by NHSScotland, has today published advice ...
Posted by Michael Wonder on 09 May 2025
Osimertinib mesylate in combination with pemetrexed disodium heptahydrate and platinum-based chemotherapy for patients with advanced EGFR mutation positive non-small-cell lung cancer (final guidance)
8 May 2025 - Osimertinib mesylate, when used in combination with pemetrexed disodium heptahydrate and platinum-based chemotherapy, is recommended as an ...
Posted by Michael Wonder on 09 May 2025
Itulatek approved for treatment of children and adolescents in Canada
8 May 2025 - ALK today announced that Health Canada has approved ALK’s regulatory filing for Itulatek (tree pollen sublingual allergy ...
Posted by Michael Wonder on 08 May 2025
FDA grants accelerated approval to the combination of avutometinib and defactinib for KRAS-mutated recurrent low-grade serous ovarian cancer
8 May 2025 - Today, the FDA granted accelerated approval to the combination of avutometinib and defactinib (Avmapki Fakzynja Co-pack, ...
Posted by Michael Wonder on 08 May 2025
Brentuximab vedotin in combination with chemotherapy for the treatment of patients with stage 3 or 4 CD30 positive Hodgkin lymphoma
7 May 2025 - Brentuximab vedotin, when used in combination with doxorubicin hydrochloride, dacarbazine and vinblastine sulphate is recommended as an ...
Posted by Michael Wonder on 08 May 2025
MHRA approves teprotumumab as the first UK treatment for adults with moderate to severe thyroid eye disease
7 May 2025 - The MHRA has today approved teprotumumab (Tepezza). ...
Posted by Michael Wonder on 08 May 2025
European Commission approves Tremfya (guselkumab), the first dual-acting IL-23 inhibitor offering both subcutaneous and intravenous induction options, for adult patients with moderately to severely active Crohn's disease
7 May 2025 - Data from the pooled GALAXI 2 and 3 studies showed that guselkumab demonstrated greater efficacy compared to ...
Posted by Michael Wonder on 07 May 2025
Omaveloxolone for the treatment of patients with Friedreich’s ataxia
6 May 2025 - NICE is unable to make a recommendation on the use of omaveloxolone (Skyclarys) for the treatment of ...
Posted by Michael Wonder on 06 May 2025
Health Canada has granted approval for Tzield, the first and only disease-modifying therapy in auto-immune type 1 diabetes in Canada
5 May 2025 - Tzield is demonstrated to delay by a median of 2 years the onset of Stage 3 type ...
Posted by Michael Wonder on 06 May 2025
Teva and Alvotech announce FDA approval of interchangeability for Selarsdi (ustekinumab-aekn) with Stelara (ustekinumab)
5 May 2025 - The US FDA has approved Selarsdi (ustekinumab-aekn) as interchangeable with the reference biologic Stelara (ustekinumab) in all ...
Posted by Michael Wonder on 03 May 2025
Vimkunya vaccine approved to prevent disease caused by the chikungunya virus in people 12 years of age and older
1 May 2025 - The MHRA has today approved a vaccine (Vimkunya) used to prevent disease caused by the chikungunya virus ...
Posted by Michael Wonder on 02 May 2025
Satsuma Pharmaceuticals announces US FDA approval for Atzumi (dihydroergotamine) nasal powder for the acute treatment of migraine
30 April 2025 - Atzumi is the first and only product utilising the SMART (Simple MucoAdhesive Release Technology) platform which combines ...
Posted by Michael Wonder on 01 May 2025
Up to 1,000 women a year could benefit from new at-home treatment for endometriosis
1 May 2025 - Our final draft guidance recommends linzagolix (Yselty, Theramex) with hormonal add-back therapy for adults of reproductive age ...