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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 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
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
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 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 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
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
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 05 Sep 2025
Agios provides update on US PDUFA goal date for Pyrukynd (mitapivat) in thalassemia
4 September 2025 - Agios Pharmaceuticals today announced that the US FDA has extended the PDUFA goal date for the supplemental ...
Posted by Michael Wonder on 04 Sep 2025
Lilly's olomorasib receives US FDA's breakthrough therapy designation for the treatment of certain newly diagnosed metastatic KRAS G12C-mutant lung cancers
4 September 2025 - The breakthrough therapy designation for olomorasib is based on data from the Phase 1/2 LOXO-RAS-20001 trial and ...