Chester County News and Community Website
WILMINGTON, DE — AstraZeneca has secured U.S. regulatory approval for IMFINZI (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) therapy for adults with previously untreated high-risk non-muscle-invasive bladder cancer, expanding the …
AstraZeneca Wins FDA Approval for IMFINZI in Early Bladder Cancer Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration has released draft guidance that could shorten development timelines for gene therapies by allowing drugmakers to make greater use of existing …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
PHILADELPHIA, PA — Medicus Pharma (Nasdaq: MDCX) has advanced its SkinJect® treatment into registrational development for Gorlin Syndrome, a rare genetic disorder that causes recurring skin cancers and often requires …
Medicus Pharma Seeks FDA Path for Rare Skin Cancer Disorder 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
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
WASHINGTON, D.C. — The U.S. Food and Drug Administration issued warning letters to eight retailers accused of selling unauthorized nicotine pouches and dissolvable tobacco products designed to resemble candy, cough …
FDA Targets Retailers Selling Tobacco Products Resembling Candy 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