Chester County News and Community Website
WASHINGTON, D.C. — The U.S. Food and Drug Administration has released draft guidance that could shorten development timelines for gene therapies by allowing drugmakers to make greater use of existing …
FDA Issues Gene Therapy Guidance Aimed at Faster Reviews Read More
HORSHAM, PA — The U.S. Food and Drug Administration has approved a label expansion for Johnson & Johnson’s (NYSE: JNJ) TREMFYA, allowing the company to market clinical evidence showing the …
FDA Expands TREMFYA Label to Include Joint Damage Data in Psoriatic Arthritis Read More
WILMINGTON, DE — AstraZeneca and Daiichi Sankyo have secured U.S. approval for DATROWAY as a first-line treatment for certain patients with metastatic triple-negative breast cancer, expanding treatment options in a …
AstraZeneca, Daiichi Sankyo Win FDA Approval for DATROWAY in Breast Cancer Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration has proposed reducing animal testing requirements for certain cancer therapies, a shift that could lower development costs and shorten preclinical timelines …
FDA Moves to Cut Animal Testing for Some Cancer Drugs Read More
WILMINGTON, DE — AstraZeneca received U.S. regulatory approval for BAXFENDY (baxdrostat), a new treatment for adults with uncontrolled hypertension, marking the first new drug class for the condition in years …
FDA Clears AstraZeneca Blood Pressure Drug, Expanding Options for Uncontrolled Hypertension Read More
HARRISBURG, PA — Pennsylvania election officials on Friday began a statewide post-election audit of the May 19 primary, a review designed to verify the accuracy of the reported outcome in …
Pennsylvania Begins Audit of Statewide Primary Election Results Read More
HARRISBURG, PA — The U.S. Department of Agriculture is directing more than $2.2 million to two rural Pennsylvania infrastructure projects aimed at expanding healthcare access and emergency preparedness, investments expected …
USDA Directs $2.2 Million to Rural Health, Emergency Projects in PA Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration approved Hepcludex as the first authorized treatment for chronic hepatitis delta virus infection in the United States, giving patients with the …
FDA Clears First Hepatitis Delta Treatment for U.S. Market Read More
BALA CYNWYD, PA — Larimar Therapeutics, Inc. (Nasdaq: LRMR) plans to begin a rolling FDA biologics license application submission next month for its experimental Friedreich’s ataxia treatment nomlabofusp as the …
Larimar Targets FDA Filing for Friedreich’s Ataxia Drug Read More
PHILADELPHIA, PA — Lannett Company announced that the U.S. Food and Drug Administration approved LANGLARA, an interchangeable biosimilar to Lantus insulin, expanding the number of lower-cost insulin treatment options available …
FDA Approves Interchangeable Lantus Biosimilar for Diabetes Read More