
Rezolute, Inc. Receives FDA Orphan Drug Designation for Ersodetug for Hypoglycemia Due to Tumor Hyperinsulinism
Rezolute, Inc., a leading late-stage biopharmaceutical company focused on developing transformative therapies for rare diseases, announced that the U.S. Food and Drug Administration (FDA) has granted ...

Aquestive Therapeutics Receives Positive FDA Feedback for Anaphylm™ (Epinephrine) Sublingual Film
Aquestive Therapeutics Receives Positive FDA Feedback for Anaphylm™ (Epinephrine) Sublingual Film Aquestive Therapeutics, Inc., a trailblazing pharmaceutical company dedicated to improving patients ...

FDA Accepts Cytokinetics’ NDA for Aficamten to Treat Obstructive Hypertrophic Cardiomyopathy
FDA Accepts Cytokinetics' NDA for Aficamten to Treat Obstructive Hypertrophic Cardiomyopathy Cytokinetics, Incorporated today announced that the U.S. Food & Drug Administration (FDA) has accepted ...

FDA Grants Orphan Drug Designation to AAVantgarde Bio’s AAVB-081 for Usher Syndrome Type 1B Treatment
FDA Grants Orphan Drug Designation to AAVantgarde Bio's AAVB-081 for Usher Syndrome Type 1B Treatment AAVantgarde Bio (AAVantgarde), a clinical-stage, Italian-based international biotechnology company ...