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Food and Drug Administration

Product of USA
National

New ‘Product of USA’ Label Targets Consumer Confusion

March 30, 2026March 29, 2026 - by Maryann Pugh

WASHINGTON, D.C. — Consumers will see clearer labeling on meat, poultry, and egg products under a new federal standard designed to ensure items labeled “Product of USA” are entirely sourced …

New ‘Product of USA’ Label Targets Consumer Confusion Read More

FDA
Health / Medical / National

FDA Approves First Gene Therapy for Rare Childhood Immune Disorder

March 30, 2026March 29, 2026 - by Maryann Pugh

WASHINGTON, D.C. — Children with a life-threatening immune disorder now have a new treatment option following federal approval of the first gene therapy designed to correct the underlying cause of …

FDA Approves First Gene Therapy for Rare Childhood Immune Disorder Read More
Johnson & Johnson
Regional

FDA Approves Johnson & Johnson Psoriasis Drug ICOTYDE

March 29, 2026March 28, 2026 - by Timothy Alexander

SPRING HOUSE, PA — Johnson & Johnson (NYSE: JNJ) said the U.S. Food and Drug Administration has approved ICOTYDE (icotrokinra) for the treatment of moderate-to-severe plaque psoriasis in adults and …

FDA Approves Johnson & Johnson Psoriasis Drug ICOTYDE Read More

U.S. Food and Drug Administration
Medical Products / National

FDA Approves First Treatment Targeting Hunter Syndrome Brain Effects

March 29, 2026March 29, 2026 - by Maryann Pugh

WASHINGTON, D.C. — Children with a rare genetic disorder that affects the brain and body will have access to a newly approved treatment designed to slow disease progression, federal regulators …

FDA Approves First Treatment Targeting Hunter Syndrome Brain Effects Read More
NRx Pharmaceuticals
Regional

NRx Says FDA Finds No Bioequivalence Issues in Ketamine Filing

March 24, 2026March 23, 2026 - by Timothy Alexander

WILMINGTON, DE — NRx Pharmaceuticals Inc. (Nasdaq: NRXP) said the U.S. Food and Drug Administration has not identified bioequivalence deficiencies in its abbreviated new drug application for a preservative-free ketamine …

NRx Says FDA Finds No Bioequivalence Issues in Ketamine Filing Read More

NRx Pharmaceuticals
Regional

NRx Says FDA Will Review NRX-100 Without New Trials

March 24, 2026March 23, 2026 - by Timothy Alexander

WILMINGTON, DE — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) said it has received written confirmation from the U.S. Food and Drug Administration supporting a path toward approval of its depression treatment …

NRx Says FDA Will Review NRX-100 Without New Trials Read More
GSK plc
Regional

FDA Expands GSK RSV Vaccine Use to At-Risk Adults Ages 18–49

March 23, 2026March 22, 2026 - by Timothy Alexander

PHILADELPHIA, PA — GSK plc (NYSE: GSK) said the U.S. Food and Drug Administration has expanded approval of its RSV vaccine AREXVY to include adults ages 18 to 49 who …

FDA Expands GSK RSV Vaccine Use to At-Risk Adults Ages 18–49 Read More

Woman in oversized pants
National

FDA Fast-Tracks Higher-Dose Weight Loss Drug Approval

March 22, 2026March 22, 2026 - by Maryann Pugh

WASHINGTON, D.C. — A new higher-dose version of a widely used weight loss drug has been approved on an accelerated timeline, offering patients another treatment option as federal regulators test …

FDA Fast-Tracks Higher-Dose Weight Loss Drug Approval Read More
Mouse
National

FDA Push to Replace Animal Testing Signals Major Shift

March 22, 2026March 22, 2026 - by Maryann Pugh

WASHINGTON, D.C. — Federal regulators are moving to reduce the use of animal testing in drug development, issuing new guidance to help drugmakers adopt alternative methods that rely on human-based …

FDA Push to Replace Animal Testing Signals Major Shift Read More
AstraZeneca
Cancer / Regional

FDA Grants Priority Review to ENHERTU for Early Breast Cancer Use

March 20, 2026March 19, 2026 - by Timothy Alexander

WILMINGTON, DE — The U.S. Food and Drug Administration has accepted and granted Priority Review to a supplemental application for ENHERTU, a breast cancer treatment developed by AstraZeneca and Daiichi …

FDA Grants Priority Review to ENHERTU for Early Breast Cancer Use Read More

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