Chester County News and Community Website
NEWTOWN, PA — Helius Medical Technologies, Inc. (NASDAQ: HSDT) has filed a 510(k) submission with the U.S. Food and Drug Administration seeking to expand the label of its Portable Neuromodulation …
Helius Files FDA Submission for PoNS Stroke Therapy Label Expansion Read More
WILMINGTON, DE — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) announced it has received U.S. Food and Drug Administration (FDA) approval of a Suitability Petition allowing the company to proceed with its …
NRx Wins FDA Nod to Advance Preservative-Free Ketamine Product KETAFREE Read More
KING OF PRUSSIA, PA — SEED Therapeutics, Inc. announced it has closed a $30 million Series A-3 financing and received U.S. Food and Drug Administration clearance of its Investigational New …
SEED Therapeutics Secures $30M Funding, Gains FDA Clearance for Lead Drug Read More
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