Chester County News and Community Website
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
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
EXTON, PA — ProRx Pharma announced it has received a DEA Controlled Substances Registration Certificate, authorizing the company to handle and distribute select controlled substances. The certification expands ProRx’s ability …
ProRx Pharma Secures DEA Certification to Handle Controlled Substances 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. Department of Labor last week announced a series of actions ranging from new training for federal contractors to major enforcement initiatives aimed at protecting workers’ …
Labor Dept. Targets Unsafe Jobs, Visa Abuse, and Job Losses in Sweeping Actions 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
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