The Food and Drug Administration (FDA) has granted Orphan Drug designation to ersodetug (RZ358) for the treatment of hypoglycemia due to tumor hyperinsulinism (HI). Tumor HI is a rare condition that ...
A marketing authorization for Zegalogue (dasiglucagon, Zealand Pharma) for the treatment of severe hypoglycemia in patients aged 6 years and older with diabetes has been recommended by the European ...
Phase 3 registrational trial for ersodetug in patients with tumor hyperinsulinism (HI) expected to commence in 2025; real-world patient benefit demonstrated in Expanded Access Program REDWOOD CITY, ...
According to the CRL, the Agency identified deficiencies, not specific to dasiglucagon, following an inspection at a third-party contract manufacturing facility. The Food and Drug Administration (FDA) ...
Company believes that data from sunRIZE and the Expanded Access Program (EAP) provide evidence of activity of ersodetug in ...
Rezolute's Ersodetug Gets Orphan Drug Designation To Treat Hypoglycemia Due To Tumor Hyperinsulinism
(RTTNews) - Rezolute, Inc. (RZLT),a late-stage biopharmaceutical company, Tuesday said that the U.S. Food and Drug Administration or FDA has granted orphan drug designation to ersodetug for the ...
As patients transition to geriatric care, considerations about treatment-related side effects, polypharmacy, comorbidities, and life expectancy become paramount. This is especially true for older ...
"FDA's granting of Orphan Drug Designation is a recognition of the serious unmet need patients with tumor hyperinsulinism face and validates the potential significant benefit that ersodetug can ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback