Chester County News and Community Website
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
WASHINGTON, D.C. — Federal regulators have cleared the way for certain pancreatic cancer patients to access an experimental drug earlier than usual, approving a rapid pathway that allows treatment outside …
FDA Fast-Tracks Access to Experimental Pancreatic Drug Read More WASHINGTON, D.C. — Federal regulators are proposing new limits on the compounding of several widely used diabetes and weight-loss drugs, a move that could reduce access to lower-cost alternatives when …
FDA Moves to Restrict Compounded Weight-Loss Drugs Read More
WASHINGTON, D.C. — Federal regulators report that most infant formula sold in the United States meets high safety standards following the largest-ever review of chemical contaminants, though officials say monitoring …
FDA Finds Low Contaminants in Infant Formula Supply Read More
WASHINGTON, D.C. — Federal regulators are moving to speed up drug development by launching real-time clinical trials that allow safety data and results to be reviewed as studies are underway …
FDA Pushes Faster Drug Approvals With Real-Time Trials 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