Chester County News and Community Website
WILMINGTON, DE — AstraZeneca PLC (NASDAQ: AZN) and Japan’s Daiichi Sankyo said the U.S. Food and Drug Administration has approved ENHERTU in combination with pertuzumab as a first-line treatment for …
FDA Clears ENHERTU Combo as First-Line Breakthrough in HER2 Breast Cancer Read More
HORSHAM, PA — Johnson & Johnson (NYSE: JNJ) has won U.S. Food and Drug Administration approval for RYBREVANT FASPRO, the first and only subcutaneous therapy for patients with EGFR-mutated non-small …
FDA Clears Five-Minute Lung Cancer Shot, Redefining EGFR Treatment Read More
WAYNE, PA — Palvella Therapeutics, Inc. (Nasdaq: PVLA) said the U.S. Food and Drug Administration has granted Fast Track designation to QTORIN™ rapamycin for the treatment of angiokeratomas, a rare …
FDA Fast Track Puts Palvella’s Rare Skin Drug on a Faster Regulatory Path Read More
WASHINGTON, D.C. — The Food and Drug Administration moved aggressively in mid-December to speed promising drug reviews, loosen long-standing evidence barriers, strengthen food recall enforcement, and court private-sector innovation, signaling …
FDA Accelerates Cures, Cracks Down on Recalls, and Rewrites the Rules of Review Read More HORSHAM, PA — Johnson & Johnson (NYSE: JNJ) said the U.S. Food and Drug Administration has approved an expanded indication for AKEEGA, clearing the first FDA-approved precision medicine combination for …
FDA Clears Breakthrough Precision Combo for Aggressive Prostate Cancer Read More
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