Chester County News and Community Website
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
LANGHORNE, PA — Savara Inc. (Nasdaq: SVRA) has initiated the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for MOLBREEVI, a potential …
Savara Begins FDA Submission for Rare Lung Disease Treatment 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