Blog
RSS FeedPosted by Michael Wonder on 25 Jun 2025
FDA approves Benlysta (belimumab) auto-injector for children with active lupus nephritis
24 June 2025 - With this approval, paediatric patients aged five years and older with active lupus nephritis will have ...
Posted by Michael Wonder on 24 Jun 2025
Ozempic receives EU recommendation in peripheral arterial disease, cementing the broad benefits of semaglutide for people with type 2 diabetes and co-morbidities
23 June 2025 - Pending a decision from the European Commission, Ozempic (once weekly semaglutide) will have the broadest approved label ...
Posted by Michael Wonder on 24 Jun 2025
EMA recommends market approval of AVT06, Alvotech’s proposed biosimilar to Eylea (aflibercept)
23 June 2025 - Alvotech and Advanz Pharma today announced that the EMA's CHMP adopted a positive opinion recommending approval for ...
Posted by Michael Wonder on 24 Jun 2025
Sarclisa recommended for EU approval by the CHMP to treat transplant-eligible newly diagnosed multiple myeloma
23 June 2025 - Recommendation based on GMMG-HD7 Phase 3 study demonstrating that Sarclisa with bortezomib, lenalidomide, and dexamethasone induction treatment significantly ...
Posted by Michael Wonder on 23 Jun 2025
FDA grants accelerated approval to datopotamab deruxtecan-dlnk for EGFR-mutated non-small cell lung cancer
23 June 2025 - Today, the FDA granted accelerated approval to datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo) for adults with locally ...
Posted by Michael Wonder on 23 Jun 2025
MHRA approves UK’s first anti-PD-1 monoclonal antibody for treatment of aggressive form of lung cancer
20 June 2025 - The MHRA has today approved serplulimab (Hetronifly) to treat adults with extensive-stage small cell lung cancer, which ...
Posted by Michael Wonder on 21 Jun 2025
European Medicines Agency CHMP recommends EU approval of Partner Therapeutics Imreplys (sargramostim, rhu GM-CSF) to treat exposure to myelosuppressive doses of radiation (Haematopoietic Sub-syndrome of Acute Radiation Syndrome)
20 June 2025 - Partner Therapeutics today announced that the CHMP of the EMA has recommended approval of PTx's marketing authorisation ...
Posted by Michael Wonder on 20 Jun 2025
Recommendations made by the PBAC - May 2025
20 June 2025 - The recommendations from the May 2025 PBAC intracycle meeting are now available. ...
Posted by Michael Wonder on 20 Jun 2025
Cycle Pharmaceuticals’ Harliku (nitisinone) tablets receive first FDA approval as treatment for alkaptonuria
19 June 2025 - Cycle Pharmaceuticals announced that the FDA has approved Harliku (nitisinone) tablets for the reduction of urine homogentisic ...
Posted by Michael Wonder on 20 Jun 2025
Dupixent (dupilumab) approved in the US as the only targeted medicine to treat patients with bullous pemphigoid
20 June 2025 - Approval based on pivotal results showing improvements in sustained disease remission and reductions in itch and oral ...
Posted by Michael Wonder on 20 Jun 2025
Zemcelpro (UM171 cell therapy) receives positive CHMP opinion for treatment of blood cancer patients without access to suitable donor cells
19 June 2025 - ExCellThera announced today the CHMP of the EMA has adopted a positive opinion, recommending granting conditional marketing ...
Posted by Michael Wonder on 19 Jun 2025
Final draft guidance finds benefits of two treatments for patients with Alzheimer’s disease remain too small to justify the additional cost to the NHS
19 June 2025 - The benefits from donanemab (Kisunla; Eli Lilly) and lecanemab (Leqembi; Eisai) - remain too small to justify ...
Posted by Michael Wonder on 19 Jun 2025
Tislelizumab for the treatment of adults with advanced non-small-cell lung cancer after platinum-based chemotherapy
19 June 2025 - NICE is unable to make a recommendation on the use of tislelizumab (Tevimbra) for the treatment of ...
Posted by Michael Wonder on 19 Jun 2025
Atezolizumab for the adjuvant treatment of patients with resected non-small-cell lung cancer
19 June 2025 - NICE has published final evidence-based recommendations on the use of atezolizumab (Tecentriq) for the adjuvant treatment ...
Posted by Michael Wonder on 19 Jun 2025
Kye Pharmaceuticals receives Health Canada approval for new dosing guidance for Firdapse and an additional paediatric indication
17 June 2025 - Kye Pharmaceuticals today announced that Health Canada has approved its supplemental new drug submission regarding the recommended ...