"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 ...
Is diabetes reversible? Here, endocrinologists explain the answer, including which types of diabetes can go into "remission" ...
REDWOOD CITY, Calif., May 05, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage rare disease company focused on treating hypoglycemia caused by HI, ...
July 24 (Reuters) - The U.S. Food and Drug Administration approved Eli Lilly and Co's treatment for severe hypoglycemia, the health regulator said on Wednesday. Hypoglycemia is a condition in which ...
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Amylyx Pharmaceuticals Advances Phase 3 Study for Post-Bariatric Hypoglycemia Treatment
Amylyx Pharmaceuticals, Inc. (($AMLX)) announced an update on their ongoing clinical study. Amylyx Pharmaceuticals, Inc. is conducting a Phase 3 ...
As new insulin analogs and devices become available, we recommend including in future trials and studies patients with recent SH or IAH and then separately reporting changes in HbA 1c level, SH, and ...
Rezolute received an orphan-drug designation from the Food and Drug Administration for its treatment of hypoglycemia, or low blood sugar, caused by a disease in which a tumor produces too much insulin ...
Risk factors for hypoglycemia include mismatch of insulin timing, amount or type of carbohydrate intake, taking oral secretagogues without adequate carbohydrate intake, history of severe hypoglycemia, ...
Breakthrough Therapy Designation granted based on key positive data from the Phase 2b (RIZE) study and current unmet medical need in congenital hyperinsulinism (HI) Ersodetug continues to advance in ...
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, ...
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