Sobi Reports the US FDA’s BLA Acceptance of Nanoecapsulated Sirolimus + Pegadricase for Uncontrolled Gout

Shots:The US FDA has accepted the BLA of Nanoecapsulated Sirolimus + Pegadricase (NASP; Q4W) for the treatment of uncontrolled gout (PDUFA: Jun 27, 2026)BLA was supported by P-III (DISSOLVE I & II) trials evaluating 2 NASP doses vs PBO in adults with uncontrolled gout, which met its 1EP of sustained decrease in serum…

ByRidhi RastogiSeptember 10, 2025

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PBI-Gordon Companies Reports US Availability of Felycin-CA1 to Treat Feline Hypertrophic Cardiomyopathy

Shots:PBI-Gordon Companies has reported US availability of Felycin-CA1 (sirolimus delayed-release tablets) via licensed veterinariansFelycin-CA1 has been conditionally approved by the US FDA for managing ventricular hypertrophy in cats with subclinical hypertrophic cardiomyopathy (HCM) based on RAPACAT studyThe company is seeking a full new animal drug approval of Felycin-CA1 for cats with HCM through the…

ByRidhi RastogiJuly 31, 2025

Sobi Reports the US FDA’s BLA Acceptance of Nanoecapsulated Sirolimus + Pegadricase for Uncontrolled Gout

PBI-Gordon Companies Reports US Availability of Felycin-CA1 to Treat Feline Hypertrophic Cardiomyopathy

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