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WASHINGTON, D.C. — The U.S. Food and Drug Administration isn’t just making a suggestion—it’s drawing a line in the sand. Last week, the FDA proposed a hard-hitting rule to establish standardized …
FDA Takes Bold Stand to Protect Consumers with Standardized Asbestos Testing in Talc-Based Cosmetics Read More
WASHINGTON, D.C. — The fight against obstructive sleep apnea (OSA) has taken a monumental leap forward. For the first time, the U.S. Food and Drug Administration (FDA) has approved a drug …
FDA Approves Zepbound in Landmark Move to Battle Obstructive Sleep Apnea Read More
WASHINGTON, D.C. — A seismic shift in pediatric medical care has arrived with the FDA’s approval of Ryoncil (remestemcel-L-rknd), a revolutionary therapy aimed at tackling the devastating condition known as steroid-refractory …
FDA Approves Groundbreaking Cell Therapy for Life-Threatening Pediatric Disease Read More
WASHINGTON, D.C. — A breakthrough in life-saving medical technology has arrived. The U.S. Food and Drug Administration (FDA) has officially approved Symvess, the first acellular tissue-engineered vessel designed to repair damaged …
FDA Approves First-Ever Tissue-Engineered Vessel for Vascular Trauma Read More
WASHINGTON, D.C. — Nutrition just got a major overhaul, and it’s long overdue. The U.S. Food and Drug Administration (FDA) has announced a new, stricter definition for the term “healthy” as …
FDA Redefines ‘Healthy’ to Combat America’s Diet-Related Health Crisis Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has approved Crenessity (crinecerfont) for use alongside glucocorticoids in managing classic congenital adrenal hyperplasia (CAH) in patients aged four and older. …
FDA Approves Crenessity for Treating Classic Congenital Adrenal Hyperplasia Read More
MALVERN, PA — Endo, Inc. (OTCQX: NDOI) has secured U.S. Food and Drug Administration (FDA) approval for the commercial production of VASOSTRICT® (vasopressin injection, USP) at its newly constructed aseptic manufacturing …
Endo Receives FDA Approval for New Sterile Injectable Facility in India Read More
SPRING HOUSE, PA — Johnson & Johnson has submitted two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA), aiming to expand the use of TREMFYA® (guselkumab) …
Johnson & Johnson Seeks FDA Approval to Expand TREMFYA® Use for Pediatric Conditions Read More
EXTON, PA — Lungpacer Medical announced that its AeroPace® System has received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA). The approval marks a pivotal moment in …
Lungpacer Medical’s AeroPace System Gains FDA Approval, Transforming Respiratory Care Read More SPRING HOUSE, PA – Johnson & Johnson (NYSE: JNJ) has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval for a subcutaneous (SC) …
Johnson & Johnson Advances Ulcerative Colitis Treatment with FDA Filing for TREMFYA® Subcutaneous Regimen Read More