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Food and Drug Administration

Food and Drug Administration
National

FDA to Replace Animal Testing with Human-Relevant Methods for Drug Development

April 13, 2025April 13, 2025 - by Maryann Pugh

WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has announced an ambitious effort to modernize drug testing by reducing reliance on animal models in favor of advanced, human-relevant …

FDA to Replace Animal Testing with Human-Relevant Methods for Drug Development Read More

AstraZeneca
Regional

FDA Approves AstraZeneca’s IMFINZI® for Muscle-Invasive Bladder Cancer

April 7, 2025April 6, 2025 - by Timothy Alexander

WILMINGTON, DE — AstraZeneca‘s IMFINZI® (durvalumab) has gained FDA approval for use in adult patients with muscle-invasive bladder cancer (MIBC), making it the first perioperative immunotherapy available in the U.S. …

FDA Approves AstraZeneca’s IMFINZI® for Muscle-Invasive Bladder Cancer Read More
Martin A Makary M.D., M.P.H.
National

Dr. Martin A. Makary Sworn in as 27th FDA Commissioner

April 6, 2025April 6, 2025 - by Maryann Pugh

WASHINGTON, D.C. — Martin A. Makary, M.D., M.P.H., a distinguished surgeon, researcher, and health policy leader, was officially sworn in on April 1 as the 27th Commissioner of Food and …

Dr. Martin A. Makary Sworn in as 27th FDA Commissioner Read More

Savara
Regional

Savara Completes BLA Submission for MOLBREEVI to Treat aPAP

March 31, 2025March 30, 2025 - by Timothy Alexander

LANGHORNE, PA — Savara Inc. (Nasdaq: SVRA) has announced the completion of its Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) for MOLBREEVI, a potential treatment …

Savara Completes BLA Submission for MOLBREEVI to Treat aPAP Read More
Medical
Regional

FDA Approves GSK’s Blujepa as First New Oral Antibiotic for UTIs in 30 Years

March 31, 2025March 30, 2025 - by Timothy Alexander

PHILADELPHIA, PA — The U.S. Food and Drug Administration (FDA) has approved GSK’s Blujepa (gepotidacin), a groundbreaking oral antibiotic for treating uncomplicated urinary tract infections (uUTIs) in adult women and adolescents …

FDA Approves GSK’s Blujepa as First New Oral Antibiotic for UTIs in 30 Years Read More

Food and Drug Administration
Health / Medical / National

FDA Approves Qfitlia: A Breakthrough Treatment Revolutionizing Hemophilia Care

March 30, 2025March 29, 2025 - by Maryann Pugh

WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has announced the approval of Qfitlia (fitusiran), a treatment designed to prevent or reduce the frequency of bleeding episodes in …

FDA Approves Qfitlia: A Breakthrough Treatment Revolutionizing Hemophilia Care Read More
U.S. Food and Drug Administration (FDA)
Health / Medical / National

FDA Unveils Key Updates on Rare Disease Advances, Food Safety, and Medical Innovations

March 30, 2025March 29, 2025 - by Maryann Pugh

WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has released a series of announcements covering a wide range of initiatives and regulatory updates, reflecting the agency’s ongoing commitment …

FDA Unveils Key Updates on Rare Disease Advances, Food Safety, and Medical Innovations Read More

U.S. Food and Drug Administration
Infectious Diseases / National

Revolution in Healthcare: FDA Greenlights First At-Home Test for Three Major STIs

March 30, 2025March 29, 2025 - by Maryann Pugh

WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has granted Visby Medical marketing authorization for its Women’s Sexual Health Test, a groundbreaking diagnostic tool that allows at-home testing …

Revolution in Healthcare: FDA Greenlights First At-Home Test for Three Major STIs Read More
Larimar Therapeutics
Regional

Larimar Therapeutics Advances Nomlabofusp Program Amid Regulatory Support

March 27, 2025March 26, 2025 - by Timothy Alexander

BALA CYNWYD, PA — Larimar Therapeutics, Inc. (Nasdaq: LRMR) has announced significant progress in its nomlabofusp program for Friedreich’s Ataxia (FA), reporting key regulatory advancements, ongoing clinical developments, and a robust …

Larimar Therapeutics Advances Nomlabofusp Program Amid Regulatory Support Read More
U.S. Food and Drug Administration
Health / Medical / National

FDA Unveils Life-Changing Drug, Urgent Device Alert, and Revolutionary Tech to Protect Your Health

March 23, 2025March 23, 2025 - by Maryann Pugh

WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has announced a series of critical updates this week, reflecting its ongoing commitment to advancing public health and medical safety. …

FDA Unveils Life-Changing Drug, Urgent Device Alert, and Revolutionary Tech to Protect Your Health Read More

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