Breakthrough therapy: Latest News, Top Stories & Analysis

RADNOR, PA — NRx Pharmaceuticals (Nasdaq: NRXP) announced that it recently filed a new Breakthrough Therapy Designation (BTD) request with the US Food and Drug Administration (FDA) focused on patients …

FDA Accepts Filings for Amicus’ AT-GAA for the Treatment of Pompe Disease

October 1, 2021September 30, 2021 - by MyChesCo

PHILADELPHIA, PA — Amicus Therapeutics (Nasdaq: FOLD) announced that the U.S. Food and Drug Administration (FDA) this week accepted for review the Biologics License Application (BLA) for cipaglucosidase alfa and …

FDA Approves First Targeted Therapy for Lung Cancer Mutation Previously Considered Resistant to Drug Therapy

June 2, 2021May 29, 2021 - by MyChesCo

WASHINGTON, D.C. — The U.S. Food and Drug Administration approved Lumakras (sotorasib) as the first treatment for adult patients with non-small cell lung cancer whose tumors have a specific type of …