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WASHINGTON, D.C. — The Food and Drug Administration rolled out a rapid-fire series of moves this month that could reshape how Americans manage chronic disease, treat rare and life-threatening blood …
FDA’s Week of Breakthroughs: New Gene Therapy, New Antibiotics, New Rules Read More
WILMINGTON, DE — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) said the U.S. Food and Drug Administration has accepted its Abbreviated New Drug Application for KETAFREE, a preservative-free intravenous ketamine product that …
NRx’s Preservative-Free Ketamine Reaches FDA Review as Company Targets 2026 Launch Read More
WILMINGTON, DE — AstraZeneca secured U.S. approval for its IMFINZI (durvalumab) regimen in combination with FLOT chemotherapy for early-stage and locally advanced gastric and gastroesophageal junction cancers, marking the first …
AstraZeneca Wins Landmark Approval for IMFINZI Regimen in Early Gastric Cancer Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration last week rolled out a sweeping slate of technology, enforcement, and approval actions that touch everything from artificial intelligence inside the …
FDA Bets Big On AI, Animal-Free Testing And High-Tech Cancer Cures Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration approved Itvisma, a new adeno-associated virus vector-based gene therapy for spinal muscular atrophy, extending treatment eligibility to adults and children 2 …
FDA Greenlights First Gene Therapy for Older SMA Patients, Raising Hope Nationwide Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration has launched a pilot program aimed at dramatically speeding up the back-and-forth communications between drug developers and federal regulators — a …
FDA Tests Rapid-Response System: Will Faster Answers Speed New Drug Development? Read More
WASHINGTON, D.C. — The long-standing FDA warnings on hormone replacement therapy for menopause are being dismantled, as the U.S. Department of Health and Human Services on Monday announced the removal …
HHS Overhauls Menopause Drug Warnings as FDA Unveils Major Women’s Health Shift Read More
HORSHAM, PA — Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration has approved DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) as the first-ever treatment for adults with …
FDA Approves First Treatment for High-Risk Smoldering Multiple Myeloma Read More
PLYMOUTH MEETING, PA — INOVIO (NASDAQ: INO) announced that it has completed the rolling submission of its Biologics License Application (BLA) for INO-3107, a DNA-based immunotherapy candidate for adults with …
INOVIO Submits FDA Application for First DNA Therapy to Treat Rare HPV Disease Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration unleashed a one-two punch this week — first targeting companies peddling dangerous counterfeit Botox online, then accelerating approval for life-saving treatments …
FDA Cracks Down on Fake Botox Sellers, Fast-Tracks Breakthrough Drugs Read More