"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 ...

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 ...

Amylyx Pharmaceuticals, Inc. (($AMLX)) announced an update on their ongoing clinical study. Amylyx Pharmaceuticals, Inc. is conducting a Phase 3 ...

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 ...

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 ...

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, ...

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 ...

Hypoglycemia occurs when blood sugar (glucose) levels fall below 70 milligrams per deciliter, creating a medical emergency that requires immediate treatment. The condition affects people with and ...

People with attention deficit hyperactivity disorder (ADHD) and diabetes may be more likely to experience hypoglycemia. Treatment for ADHD may help someone with both conditions better manage their ...

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, ...

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, ...