Chester County News and Community Website
WILMINGTON, DE — An advisory committee to the U.S. Food and Drug Administration voted 7-1, with one abstention, that AstraZeneca’s TRUQAP combination therapy demonstrated a favorable benefit-risk profile for patients …
FDA Panel Backs AstraZeneca Prostate Cancer Drug Combo Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration has approved Bizengri for adults with advanced NRG1 fusion-positive cholangiocarcinoma, marking the first approved treatment for the rare bile duct cancer …
FDA Approves Bizengri for Rare Bile Duct Cancer Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration has launched Elsa 4.0, an upgraded version of its internal artificial intelligence platform, and consolidated more than 40 agency data systems …
FDA Expands Internal AI Tools With Elsa 4.0, HALO Platform Read More
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
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