Chester County News and Community Website
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) recently released new guidelines aimed at improving the development and approval process of heartworm prevention products for dogs. This move …
FDA Releases New Guidelines for Dog Heartworm Prevention Products Read More
WEST CHESTER, PA — Verrica Pharmaceuticals Inc. (Nasdaq: VRCA) announced the settlement of a legal dispute with Dormer Laboratories, Inc. this week. As part of the agreement, Dormer Labs will …
Verrica Pharmaceuticals Settles Litigation with Dormer Labs Over Cantharidin Products Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) recently released final guidance aimed at speeding up the development and review process for new drugs designed to combat zoonotic …
FDA Issues New Guidance to Expedite Animal Drugs for Zoonotic Diseases Read More
PLYMOUTH MEETING, PA — Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) announced that the U.S. Food and Drug Administration (FDA) recently denied a Citizen Petition filed by a short seller. The …
FDA Denies Petition Challenging Safety and Efficacy of Harmony Biosciences’ Drug Read More
PHILADELPHIA, PA — Carisma Therapeutics Inc. (Nasdaq: CARM) has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its innovative cancer treatment, CT-0525. This therapy targets …
FDA Grants Fast Track Status to Carisma Therapeutics’ New Cancer Therapy Read More PLYMOUTH MEETING, PA — Harmony Biosciences (Nasdaq: HRMY) announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for WAKIX® (pitolisant) tablets. The …
FDA Approves Harmony Biosciences’ WAKIX for Pediatric Narcolepsy Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has greenlit the marketing of a ground-breaking Hepatitis C virus (HCV) test, developed by Cepheid, marking a significant step in …
FDA Approves Revolutionary Hepatitis C Test: A Game Changer in Disease Diagnosis and Management Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) is taking significant steps to ensure that clinical trials better reflect the diversity of the population they aim to serve. …
FDA Unveils Draft Guidance to Boost Diversity in Clinical Trials Read More
WASHINGTON, D.C. — The Food and Drug Administration (FDA) has given its full approval to Sirturo (bedaquiline), a drug used in the treatment of pulmonary tuberculosis (TB) that is resistant …
FDA Grants Full Approval to Sirturo for Treatment of Multi-Drug Resistant Tuberculosis Read More
WASHINGTON, D.C. — The Food and Drug Administration (FDA) recently granted accelerated approval for a new treatment combination for adults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC). …
FDA Grants Accelerated Approval to New Colorectal Cancer Treatment Read More