Chester County News and Community Website
PHILADELPHIA, PA — Proscia received a new U.S. Food and Drug Administration 510(k) clearance for its Concentriq AP-Dx digital pathology platform, expanding scanner compatibility and giving the company a regulatory …
Proscia Wins FDA Clearance to Expand Digital Pathology Platform Read More
WEST CONSHOHOCKEN, PA — The U.S. Food and Drug Administration has listed a patent covering HemiClor, a 12.5-milligram chlorthalidone tablet for treating hypertension, in its Orange Book, extending intellectual property …
FDA Lists HemiClor Patent, Extending Market Protection to 2045 Read More
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
WASHINGTON, D.C. — The Food and Drug Administration licensed the first freeze-dried plasma product for U.S. use last week, creating a room-temperature option for treating adult patients when conventional plasma …
FDA Clears First Freeze-Dried Plasma for Emergency Use 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 Food and Drug Administration selected Dexcom Inc. as the first participant in a federal pilot linking digital health-device oversight with a Medicare payment model that rewards …
FDA Selects Dexcom for Medicare Digital Health Pilot 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