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RSS FeedPosted 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
Revolution Medicines announces FDA breakthrough therapy designation for daraxonrasib in previously treated metastatic pancreatic cancer with KRAS G12 mutations
23 June 2025 - Breakthrough therapy designation based on promising early clinical evidence observed with daraxonrasib in patients with pancreatic ductal ...
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 24 Jun 2025
Australians with cystic fibrosis benefit from life changing expanded listing
24 June 2025 - More Australians living with cystic fibrosis will have affordable access to a life changing treatment option ...
Posted by Michael Wonder on 23 Jun 2025
‘Barriers lifted’: cystic fibrosis treatment reaches final waiting patients
23 June 2025 - Ex-Wallabies player Nathan Charles has lived with cystic fibrosis for decades. ...
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 22 Jun 2025
‘The sky’s the limit’: how Australian scientists rewrote the cancer script
20 June 2025 - A major shift in cancer treatment will be publicly funded and is set to dramatically increase the ...
Posted by Michael Wonder on 22 Jun 2025
Update on FDA review of ruxolitinib cream (Opzelura) for children ages 2-11 with atopic dermatitis
20 June 2025 - Incyte today announced that the US FDA has extended the review period for the supplemental new ...
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
UNAIDS urges Gilead to drop price of new HIV prevention shot
18 June 2025 - The US FDA has approved long-acting injectable lenacapavir for HIV prevention. The new medicine is administered ...