Chester County News and Community Website
MALVERN, PA — The U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy designation to Ocugen Inc.’s experimental OCU410 gene therapy for geographic atrophy, giving the blindness treatment access …
FDA Gives Ocugen Gene Therapy Expedited Regulatory Status Read More
PHILADELPHIA, PA — Medicus Pharma Ltd. received FDA clearance to begin a registrational Phase 2b trial of its SkinJect microneedle patch in patients with Gorlin Syndrome, advancing the treatment toward …
ICYMI: FDA Clears Medicus to Begin Gorlin Syndrome SkinJect Trial Read More
WILMINGTON, DE — Inhibikase Therapeutics Inc. (Nasdaq: IKT) has received U.S. Food and Drug Administration Orphan Drug Designation for its lead pulmonary arterial hypertension drug candidate, a regulatory milestone that …
Inhibikase Wins FDA Orphan Status for PAH Drug Candidate Read More PHILADELPHIA, PA — Medicus Pharma Ltd. (Nasdaq: MDCX) received U.S. Food and Drug Administration authorization to begin a registrational Phase 2b study of its SkinJect treatment in patients with Gorlin …
FDA Clears Medicus to Start Gorlin Syndrome Drug Study Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration is revoking one petroleum-based food dye authorization and proposing to eliminate another, advancing the Trump administration’s effort to remove outdated color …
FDA Moves to Eliminate Two Food Dye Authorizations Read More
MALVERN, PA — MAXONA Pharmaceuticals has received U.S. Food and Drug Administration clearance to begin a Phase 2 clinical trial of its investigational non-opioid pain therapy, advancing the company’s effort …
FDA Clears MAXONA Pain Drug for Phase 2 Trial Read More
IVYLAND, PA — LifeLens Technologies has received expanded U.S. Food and Drug Administration 510(k) clearance for its wearable physiological monitoring platform, broadening the range of clinical measurements the device can …
LifeLens Wins Expanded FDA Clearance for Patient Monitoring Platform Read More
WASHINGTON, D.C. — The U.S. Department of Agriculture has completed the largest annual investment in the history of its Patrick Leahy Farm to School Grant Program, awarding nearly $20 million …
USDA Awards Record $20 Million for Farm-to-School Projects Read More WASHINGTON, D.C. — The Food and Drug Administration proposed easing registration requirements for distributed drug manufacturing networks last week while expanding oversight of foreign facilities that supply ingredients entering the …
FDA Plan Would Cut Drug Factory Registration Burdens Read More
WASHINGTON, D.C. — The U.S. Department of Agriculture and Small Business Administration created a formal complaint process for farmers, ranchers and small businesses challenging federal enforcement actions, expanding the Trump …
ICYMI: USDA, SBA Build Complaint System for Farm Regulation Fights Read More