Chester County News and Community Website
WILMINGTON, DE — AstraZeneca’s (NYSE: AZN) application to expand Imfinzi into another form of bladder cancer has received FDA Priority Review after a Phase III trial showed the drug combination …
FDA Speeds Review of AstraZeneca Bladder Cancer Regimen Read More
PHILADELPHIA, PA — Medicus Pharma Ltd. is seeking U.S. Food and Drug Administration approval for a redesigned late-stage development plan that could cut enrollment in its Teverelix advanced prostate cancer …
Medicus Seeks FDA Path to Cut Teverelix Trial by 60% Read More
NEWTOWN, PA — KVK-Tech Inc. completed a U.S. Food and Drug Administration inspection of its opioid risk-management compliance on Sept. 18 without receiving a Form FDA 483, indicating investigators recorded …
KVK-Tech Clears FDA Opioid Compliance Inspection Read More PHILADELPHIA, PA — Medicus Pharma Ltd. (NASDAQ: MDCX) will end internally funded development of SkinJect for sporadic nodular basal cell carcinoma and concentrate its clinical spending on Gorlin syndrome, narrowing …
ICYMI: Medicus Narrows SkinJect Program to Gorlin Syndrome Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration approved Fayuvi, a one-time gene therapy from Ultragenyx Pharmaceutical Inc., as the first treatment for children with mucopolysaccharidosis type IIIA, providing …
FDA Approves First Treatment for Sanfilippo Syndrome Type A Read More
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