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RSS FeedPosted by Michael Wonder on 12 Sep 2025
Intercept announces voluntary withdrawal of Ocaliva for primary biliary cholangitis from the US market
11 September 2025 - Intercept Pharmaceuticals today announced its decision to voluntarily withdraw Ocaliva (obeticholic acid) from the US market ...
Posted by Michael Wonder on 12 Sep 2025
Johnson & Johnson seeks first EMA approval for icotrokinra aiming to transform the plaque psoriasis treatment paradigm
11 September 2025 - Johnson & Johnson today announced the submission of an application to the EMA seeking the first approval ...
Posted by Michael Wonder on 12 Sep 2025
Sanofi’s SAR402663 earns fast track designation in the US for neovascular age-related macular degeneration
11 September 2025 - Designation earned for a one time intravitreal gene therapy with the potential to eliminate treatment burden for ...
Posted by Michael Wonder on 11 Sep 2025
Enhertu type II variation application validated in the EU for previously treated patients with HER2 positive metastatic solid tumours
11 September 2025 - Submission based on three Phase 2 trials where Daiichi Sankyo and AstraZeneca’s Enhertu showed clinically meaningful ...
Posted by Michael Wonder on 11 Sep 2025
Health Canada approves Slenyto - extended-release melatonin formulation - as a prescription drug for insomnia in children with autism spectrum disorder and Smith-Magenis syndrome
10 September 2025 - Neurim Pharmaceuticals is pleased to announce that Health Canada has granted marketing authorisation for Slenyto, an ...
Posted by Michael Wonder on 11 Sep 2025
FDA files Corcept’s new drug application for relacorilant as a treatment for patients with platinum-resistant ovarian cancer
10 September 2025 - Corcept Therapeutics today announced that the US FDA has accepted Corcept’s new drug application for relacorilant as ...
Posted by Michael Wonder on 10 Sep 2025
Greenwich LifeSciences’ GLSI-100 granted US FDA fast track designation
10 September 2025 - Greenwich LifeSciences today announced that FDA has granted fast track designation for GLSI-100 in the HLA-A*02 patient ...
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
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
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 ...