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RSS FeedPosted 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 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
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
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
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
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
Saol Therapeutics receives complete response letter from FDA for SL1009 (DCA) for the treatment of pyruvate dehydrogenase complex feficiency
8 September 2025 - Saol is seeking a path forward with the FDA that does not require an additional trial ...
Posted by Michael Wonder on 06 Sep 2025
FDA announces real-time release of complete response letters, posts previously unpublished batch of 89
4 September 2025 - The US FDA today announced that it will release future complete response letters promptly after they are ...
Posted by Michael Wonder on 06 Sep 2025
US FDA approves expanded indication for Vonvendi [von Willebrand factor (recombinant)] for adults and children with von Willebrand disease
5 September 2025 - Takeda today announced that the US FDA has approved the supplemental biologics license application for Vonvendi [von ...
Posted by Michael Wonder on 06 Sep 2025
Sol-Gel announces Health Canada approval of Epsolay
4 September 2025 - - Sol-Gel Technologies announced today that on 27 August 2 2025 Health Canada issued a Notice ...
Posted by Michael Wonder on 05 Sep 2025
FDA approves expanded use of Vonvendi for von Willebrand disease, including for certain uses for children
5 September 2025 - The US FDA today approved expanded use of Vonvendi [von Willebrand factor (recombinant)] for routine preventative ...
Posted by Michael Wonder on 05 Sep 2025
US FDA approves Henlius and Organon’s Bildyos (denosumab-nxxp) and Bilprevda (denosumab-nxxp), biosimilars to Prolia (denosumab) and Xgeva (denosumab), respectively
2 September 2025 - Shanghai Henlius Biotech and Organon today announced the US FDA has approved Bildyos (denosumab-nxxp) injection 60 mg/mL ...
Posted by Michael Wonder on 03 Sep 2025
Health Canada approves Elahere for certain types of platinum-resistant ovarian cancers
2 September 2025 - Elahere received approval through Health Canada's priority review process, based on data from the pivotal MIRASOL Phase ...
Posted by Michael Wonder on 31 Aug 2025
Moderna receives US FDA approval for updated COVID-19 vaccines targeting LP.8.1 variant of SARS-CoV-2
27 August 2025 - Moderna today announced that the US FDA has approved the supplemental biologics license applications for the ...
Posted by Michael Wonder on 31 Aug 2025
Pfizer and BioNTech’s Comirnaty receives US FDA approval for adults 65 and older and individuals ages 5 through 64 at increased risk for severe COVID-19
27 August 2025 - The 2025-2026 COVID-19 vaccine formulation targets the SARS-CoV-2 sub-lineage LP.8.1, in line with FDA guidance to more ...