Chester County News and Community Website
WASHINGTON, D.C. — The U.S. Food and Drug Administration finalized an expedited regulatory pilot that will pair drug companies with qualified research institutions to shorten the path to first-in-human clinical …
FDA Opens Expedited Drug Trial Pilot to Cut Development Delays Read More
WILMINGTON, DE — NRx Pharmaceuticals Inc. (Nasdaq: NRXP) received a revised Nov. 10 regulatory goal date for its preservative-free ketamine application after the U.S. Food and Drug Administration reclassified a …
NRx Gets Earlier FDA Goal Date for Ketamine Application Read More
COATESVILLE, PA — Pression is more than doubling its Coatesville footprint as the medical-device startup moves its Wave PRO external counterpulsation system into manufacturing and sales following federal clearance, shifting …
Pression Expands Coatesville Site as Heart Device Goes to Market Read More
WILMINGTON, DE — Prelude Therapeutics Inc. (Nasdaq: PRLD) received U.S. Food and Drug Administration clearance to begin a Phase 1 trial of PRT13722, moving its experimental KAT6A-targeting breast cancer drug …
Prelude Wins FDA Clearance to Move Breast Cancer Drug to Trial Read More
WILMINGTON, DE — AstraZeneca’s (NYSE: AZN) ETCAMAH (camizestrant) combination won accelerated U.S. approval for certain advanced breast cancer patients whose tumors develop an ESR1 mutation during first-line therapy, allowing treatment …
FDA Clears AstraZeneca Breast Cancer Regimen on Early Detection Read More
PHILADELPHIA, PA — Medicus Pharma Ltd. (NASDAQ: MDCX) received FDA authorization to begin an NDA-enabling Phase 2b study of SkinJect in patients with Gorlin Syndrome, advancing the company’s lead program …
FDA Clears Medicus SkinJect Study for Gorlin Syndrome Read More
MALVERN, PA — Psych Congress 2026 will devote five days of programming Sept. 15-19 in New Orleans to psychedelic therapies as federal policy, clinical research and patient demand push psychiatrists …
Psych Congress Expands Psychedelics Focus as Policy Shifts Read More
BLUE BELL, PA — Unisys researchers are calling for drug-repurposing AI to be judged on whether its recommendations can withstand biological, safety, and evidentiary scrutiny — not predictive accuracy alone …
Unisys Researchers Push New Standard for AI Drug Models Read More
WAYNE, PA — Palvella Therapeutics, Inc. (Nasdaq: PVLA) recently completed its U.S. application for approval of QTORIN™ rapamycin to treat microcystic lymphatic malformations, putting the Wayne-based biotechnology company on a …
ICYMI: Palvella Seeks FDA Approval for Rare-Disease Skin Therapy Read More
SPRING HOUSE, PA — Johnson & Johnson (NYSE: JNJ) secured U.S. Food and Drug Administration approval for IMAAVY to treat warm autoimmune hemolytic anemia in patients 12 and older who …
FDA Clears J&J’s IMAAVY as First Drug for Rare Blood Disease Read More