Chester County News and Community Website
WASHINGTON, D.C. — The Food and Drug Administration unveiled a series of high-profile actions last week, ranging from a potential new therapy for autism symptoms to a landmark approval of …
FDA Weighs Autism Drug, Pregnancy Risk Warning, and First Glasses to Slow Myopia Read More
WILMINGTON, DE — Incyte (Nasdaq: INCY) announced that the U.S. Food and Drug Administration has approved Opzelura (ruxolitinib) cream 1.5% for children as young as two with mild to moderate …
FDA Expands Approval of Incyte’s Opzelura to Treat Pediatric Atopic Dermatitis Read More
WILMINGTON, DE — The U.S. prescribing information for AIRSUPRA now includes results from the Phase IIIb BATURA trial, which demonstrated that the medication significantly reduced severe asthma exacerbations in patients …
AIRSUPRA Label Expanded With Evidence of Risk Reduction in Mild Asthma Read More
HORSHAM, PA — Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration has approved a subcutaneous induction regimen of TREMFYA (guselkumab) for the treatment of adults …
FDA Approves Johnson & Johnson’s Tremfya Subcutaneous Induction for Ulcerative Colitis Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration has granted accelerated approval to Forzinity (elamipretide) injection, the first treatment for Barth syndrome, a rare and life-threatening mitochondrial disease that …
FDA Approves First Drug for Rare, Fatal Barth Syndrome Read More
BLUE BELL, PA — inTRAvent Medical Partners LP announced that its SOLOPASS® 2.0 navigation system has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), advancing its platform …
inTRAvent Medical Partners Secures FDA Clearance for Next-Generation SOLOPASS® 2.0 Navigation System Read More
WASHINGTON, D.C. — The Food and Drug Administration launched a series of major enforcement and transparency initiatives last week, ranging from cracking down on deceptive pharmaceutical advertising to seizing a …
FDA Cracks Down on Drug Ads, Seizes $86M in Illegal Vapes, Pushes Non-Opioid Pain Relief Read More PHILADELPHIA, PA & LONDON — Ori Biotech announced that its IRO® platform has received Advanced Manufacturing Technology (AMT) designation from the U.S. Food and Drug Administration, marking it as one …
Ori Biotech’s IRO Platform Earns FDA Advanced Manufacturing Technology Designation Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) announced a series of actions last week aimed at strengthening consumer protections, advancing rare disease treatment development, and improving drug …
FDA Issues Series of Regulatory Actions Targeting Public Health, Transparency, and Drug Safety Read More
PLYMOUTH MEETING, PA — INOVIO (NASDAQ: INO) announced that the U.S. Food and Drug Administration has agreed to the company’s rolling submission timeline for its Biologics License Application (BLA) for …
INOVIO Advances FDA Submission for INO-3107 in Rare Disease Treatment Read More