Chester County News and Community Website
SPRING HOUSE, PA — Johnson & Johnson (NYSE: JNJ) said the U.S. Food and Drug Administration has granted Priority Review to its supplemental Biologics License Application for IMAAVY (nipocalimab-aahu) to …
FDA Grants Priority Review to J&J sBLA for IMAAVY in wAIHA Read More
NEW HOPE, PA — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) said the U.S. Food and Drug Administration granted a second Breakthrough Device Designation for its AVIM Therapy, expanding its potential …
Orchestra BioMed Gains Second FDA Breakthrough Designation Read More
WILMINGTON, DE — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) recently received a Discipline Review Letter from the U.S. Food and Drug Administration identifying only minor administrative changes for its ketamine application …
NRx Reports FDA Feedback, Progress on Ketamine Application Read More
LANGHORNE, PA — The U.S. Food and Drug Administration has extended the review period for Savara Inc.’s (Nasdaq: SVRA) biologics license application for molgramostim by three months, setting a new …
FDA Extends Review of Savara’s Molgramostim Application to November Read More
WILMINGTON, DE — The U.S. Food and Drug Administration recently approved RAPIBLYK® (landiolol) for pediatric patients from birth to under 18 years old with supraventricular tachycardia, expanding its use beyond …
FDA Approves Rapiblyk for Pediatric SVT Patients in U.S. Read More
PHILADELPHIA, PA — Medicus Pharma Ltd. (NASDAQ: MDCX) said it submitted an Orphan Drug Designation application to the U.S. Food and Drug Administration for SkinJect (D-MNA) to treat basal cell …
Medicus Pharma Submits Orphan Drug Application for SkinJect Read More
WARMINSTER, PA — Arbutus Biopharma Corporation (Nasdaq: ABUS) announced that the U.S. Food and Drug Administration has granted Fast Track designation to its drug candidate imdusiran for the treatment of …
Arbutus Drug Candidate Receives FDA Fast Track Designation Read More
HARRISBURG, PA — The Pennsylvania Aggregates and Concrete Association has signed a memorandum of understanding with the U.S. Environmental Protection Agency Region 3 to expand collaboration on environmental practices and …
PACA, EPA Region 3 Sign Agreement on Environmental Collaboration Read More WILMINGTON, DE — NRx Pharmaceuticals Inc. (Nasdaq: NRXP) recently received preliminary feedback from the U.S. Food and Drug Administration on labeling for its preservative-free ketamine product, as the company continues …
NRx Receives FDA Feedback on Ketamine Drug Labeling Read More
PHILADELPHIA, PA — The U.S. Food and Drug Administration recently granted Breakthrough Therapy Designation to plixorafenib, an investigational drug from FORE Biotherapeutics, for the treatment of adults with BRAF V600E-mutated …
FDA Grants Breakthrough Status to Fore Bio Brain Cancer Drug Read More