Chester County News and Community Website
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
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has announced a groundbreaking approval of Kebilidi (eladocagene exuparvovec-tneq), marking the first gene therapy sanctioned for the treatment of aromatic L-amino …
Revolutionary Gene Therapy Approved: Kebilidi Offers New Hope for Rare Genetic Disorder Read More SPRING HOUSE, PA — Johnson & Johnson has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to nipocalimab for treating adults with moderate-to-severe Sjögren’s …
FDA Grants Breakthrough Therapy Designation to Johnson & Johnson’s Nipocalimab for Sjögren’s Disease Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has taken a pivotal step in consumer protection by proposing the removal of oral phenylephrine as an active ingredient in over-the-counter …
FDA Proposes Removal of Oral Phenylephrine from OTC Nasal Decongestants Read More
WASHINGTON, D.C. — The latest findings from the 2024 National Youth Tobacco Survey (NYTS) reveal a significant milestone in public health: youth tobacco use in the United States has plummeted …
Youth Tobacco Use Reaches Historic Low, But Challenges Persist Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration has announced that TreeHouse Foods, Inc. is undertaking a voluntary recall of certain frozen waffle products due to potential contamination with …
FDA Issues Warning on TreeHouse Foods’ Frozen Waffle Recall Over Listeria Concerns Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration has announced a voluntary recall by Church Brothers, LLC, commonly known as Church Brothers Farms, affecting 1,271 cases of green onions …
Salmonella Alert: Urgent Recall of Green Onions Poses Severe Health Risks Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration has issued a Class I recall, the most serious type, on Medtronic’s MiniMed™ 600 and 700 series insulin pumps following reports …
Urgent FDA Recall: Medtronic Insulin Pumps Pose Serious Health Risks Due to Battery Failures Read More