Chester County News and Community Website
WASHINGTON, D.C. — The U.S. Food and Drug Administration is piloting one-day inspectional assessments across multiple regulatory programs as part of an effort to make agency oversight more targeted and …
FDA Launches Pilot Program for One-Day Inspections Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration authorized four Glas electronic nicotine delivery system products through the agency’s premarket tobacco product application pathway, marking the first authorization of …
FDA Authorizes Four Glas Vape Products With Age Controls Read More
WILMINGTON, DE — AstraZeneca said the U.S. Food and Drug Administration approved BREZTRI Aerosphere for the maintenance treatment of asthma in patients aged 12 and older, expanding the drug’s use …
AstraZeneca Wins FDA Approval for BREZTRI in Asthma Read More WILMINGTON, DE — AstraZeneca said the SAPHNELO Pen has received approval from the U.S. Food and Drug Administration for self-administration in adults with systemic lupus erythematosus receiving standard therapy.
FDA Approves AstraZeneca Lupus Autoinjector Treatment Read More
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