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RSS FeedPosted 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
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
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
Ionis receives US FDA breakthrough therapy designation for ION582 in Angelman syndrome
9 September 2025 - Pivotal Phase 3 REVEAL study enrollment on track to complete in 2026. ...
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 ...
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 09 Sep 2025
ICER publishes evidence report on treatment for non-cystic fibrosis bronchiectasis
8 September 2025 - There are significant uncertainties regarding long term efficacy of brensocatib; ICER estimates that treatment would achieve ...
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
Accrufer assigned priority review in the US by FDA in children with iron deficiency anaemia
4 September 2025 - Pending successful review, approval in the US is anticipated in 2026. ...
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 ...