Blog
RSS FeedPosted by Michael Wonder on 09 May 2025
Adagrasib for previously treated patients with advanced KRAS G12C mutation positive non-small-cell lung cancer
9 May 2025 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 09 May 2025
DoH publishes revised agenda for the July 2025 PBAC meeting
9 May 2025 - The agenda for the July 2025 PBAC meeting has been updated. ...
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
PHARMAC funds and widens access to melanoma medicines
9 May 2025 - PHARMAC is funding more medicines for people with skin cancer (melanoma), from 1 June 2025. ...
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 08 May 2025
Lilly, Novo Nordisk seek insurance coverage in Korea for diabetes drugs Mounjaro and Ozempic
2 May 2025 - In Korea, Eli Lilly and Novo Nordisk are pushing for national health insurance coverage for their ...
Posted by Michael Wonder on 08 May 2025
Patient group urges quick reimbursement of Besremi for polycythemia vera
7 May 2025 - The Korea Leukemia Patients Organization has called for the reimbursement of Besremi (ropeginterferon alfa-2b), the only ...
Posted by Michael Wonder on 07 May 2025
Adcentrx Therapeutics granted fast track designation for ADRX-0706 nectin-4 antibody drug conjugate for the treatment of advanced cervical cancer
6 May 2025 - Adcentrx Therapeutics today announced that the US FDA has granted fast track designation to its lead ...
Posted by Michael Wonder on 07 May 2025
Viridian Therapeutics receives FDA breakthrough therapy designation for veligrotug for the treatment of thyroid eye disease
7 May 2025 - Biologics license application submission for veligrotug on track for second half 2025 with a planned US ...
Posted by Michael Wonder on 07 May 2025
ImmunityBio requests an urgent meeting with FDA to address the change in the Agency’s unambiguous guidance on Jan 2025 to submit a sBLA for NMIBC BCG unresponsive papillary disease, following an inconsistent refusal to file letter on 2 May 2025
5 May 2025 - ImmunityBio today announced that the Company received a refusal to file letter from the US FDA for ...
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 ...