Chester County News and Community Website
WASHINGTON, D.C. — On Tuesday, the Food and Drug Administration (FDA) issued updated guidance on the application user fees for combination products. This revised document aims to clarify how fees …
FDA Revises Guidance on User Fees for Combination Products Read More
WASHINGTON, D.C. — On Monday, the Food and Drug Administration (FDA) approved a new diagnostic test designed to detect Candida auris (C. auris) DNA from skin swabs. This test, developed …
FDA Approves Rapid Test to Combat Deadly Candida Auris Read More
WASHINGTON, D.C. — On Monday, the Food and Drug Administration (FDA) released new guidelines aimed at improving treatment options for young children with partial onset seizures (POS). The guidance, titled …
FDA Issues New Guidance on Epilepsy Drugs for Young Children Read More
AUDUBON, PA — Globus Medical, Inc. (NYSE: GMED) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ExcelsiusFlex™ robotic navigation platform, tailored for Total Knee …
Globus Medical Gains FDA Clearance for New Knee Surgery Technology Read More
MALVERN, PA — Annovis Bio Inc. (NYSE: ANVS) has received approval from the U.S. Food and Drug Administration (FDA) to transition to a new solid form of buntanetap in future …
Annovis Bio Gains FDA Approval for New Form of Neurodegenerative Drug Read More
PHILADELPHIA, PA — Passage Bio, Inc. (NASDAQ: PASG) announced positive feedback from the U.S. Food and Drug Administration (FDA) on its proposal to evaluate PBFT02 for treating frontotemporal dementia (FTD) …
Passage Bio Receives FDA Support for Expanding Dementia Treatment Trial Read More
WASHINGTON, D.C. — The Food and Drug Administration (FDA) has notified healthcare providers about a significant disruption in the supply of BD BACTEC blood culture media bottles, a crucial tool …
FDA Warns Healthcare Providers of Blood Culture Media Bottle Shortage Read More
WASHINGTON, D.C. — The Food and Drug Administration (FDA) has released new guidelines aimed at improving the design of clinical studies for devices that treat opioid use disorder (OUD). This …
FDA Issues New Guidelines for Devices Treating Opioid Use Disorder Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) recently approved Felanorm, the first generic methimazole oral solution for treating hyperthyroidism in cats. This new medication offers a vital …
FDA Approves First Generic Methimazole Oral Solution for Cats Read More
WASHINGTON, D.C. — The Food and Drug Administration (FDA) has updated its advisory regarding Diamond Shruumz-brand products, reporting an increase in illnesses linked to these items. The agency strongly advises …
FDA Expands Advisory on Diamond Shruumz Products Amid Rising Illness Reports Read More