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RSS FeedPosted by Michael Wonder on 11 Sep 2025
Doctor treating patients with neurofibromatosis calls for rectifying inconsistent reimbursement standards for Koselugo
26 August 2025 - Last Thursday, people gathered in front of HIRA in Seoul, holding signs that read, “Ignoring doctors' ...
Posted by Michael Wonder on 11 Sep 2025
Methods used in early value assessments for NICE: a scoping review
8 September 2025 - NICE in England introduced early value assessments as an evidence-based method of accelerating access to promising ...
Posted by Michael Wonder on 10 Sep 2025
FDA approves selumetinib for pediatric patients 1 year of age and older with neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromas
10 September 2025 - Today, the FDA approved selumetinib (Koselugo, AstraZeneca Pharmaceuticals) granules and capsules for paediatric patients 1 year ...
Posted by Michael Wonder on 10 Sep 2025
FDA accepts biologics license application for Sobi's NASP for patients with uncontrolled gout
10 September 2025 - Sobi today announced that the US FDA has accepted the biologics license application seeking approval for Nanoecapsulated ...
Posted by Michael Wonder on 10 Sep 2025
Review panel backs expanded indications for Keytruda, Dupixent; Imfinzi sent for reconsideration
5 September 2025 - HIRA's Pharmaceutical Reimbursement Evaluation Committee (PREC) has determined that the expanded indications for MSD's immuno-oncology drug ...
Posted by Michael Wonder on 10 Sep 2025
Alberta man pushes Feds to approve new Alzheimer’s drugs Leqembi and Kinsula
9 September 2025 - An Alberta man living with Alzheimer’s disease is calling on Ottawa to approve two new drugs ...
Posted by Michael Wonder on 10 Sep 2025
US FDA approval of Inlexzo (gemcitabine intravesical system) set to transform how certain bladder cancers are treated
9 September 2025 - First and only drug releasing system to provide extended local delivery of a cancer medication into the ...
Posted by Michael Wonder on 10 Sep 2025
Teva’s emrusolmin granted US FDA fast track designation for treatment of multiple system atrophy
9 September 2025 - Teva Pharmaceuticals today announced that the US FDA granted fast track designation for Teva’s investigational therapy emrusolmin ...
Posted by Michael Wonder on 10 Sep 2025
Partner Therapeutics receives EMA approval of Imreplys (sargramostim, rhu GM-CSF) to treat exposure to myelosuppressive doses of radiation (haematopoietic sub-syndrome of acute radiation syndrome
9 September 2025 - Approval based upon Imreplys significantly improving survival, accelerating recovery of white blood cells and platelets, and ...
Posted by Michael Wonder on 10 Sep 2025
Enhanced access to generalised myasthenia gravis treatments: UCB Canada secures pCPA agreements for Zilbrysq and Rystiggo
9 September 2025 - Important milestone brings eligible Canadians living with generalised myasthenia gravis one step closer to accessing innovative ...
Posted by Michael Wonder on 10 Sep 2025
FDA grants fast track designation to NS-229 for the treatment of eosinophilic granulomatosis with polyangiitis
9 September 2025 - NS Pharma, a subsidiary of Nippon Shinyaku, announced today that the US FDA has granted fast track ...
Posted by Michael Wonder on 10 Sep 2025
Health Canada approves Bylvay (odevixibat) for the treatment of cholestatic pruritus in patients with Alagille syndrome
9 Settember 2025 - Bylvay is the first and only medication approved in Canada for the treatment of both Alagille ...
Posted by Michael Wonder on 09 Sep 2025
ICER releases draft evidence report on treatments for obesity
9 September 2025 - Public comment period now open until 6 October 2025; requests to make oral comment during public ...
Posted by Michael Wonder on 09 Sep 2025
FDA approves gemcitabine intravesical system for non-muscle invasive bladder cancer
9 September 2025 - Today, the FDA approved gemcitabine intravesical system (Inlexzo, Janssen) for adults with Bacillus Calmette-Guérin unresponsive non-muscle ...
Posted by Michael Wonder on 09 Sep 2025
Revisiting the FDA’s accelerated approval pathway
8 September 2025 - After aducanumab’s accelerated approval for Alzheimer's disease, and prompted by long standing concerns regarding the accelerated approval pathway ...