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WASHINGTON, D.C. — The U.S. Food and Drug Administration signaled a sweeping shift in how cutting-edge therapies reach patients this month, unveiling regulatory flexibility for cell and gene therapies, modernizing …
FDA Clears Faster Path for Gene Cures as Rare Disease Breakthrough Arrives Read More
PHILADELPHIA, PA — A rare-disease gene therapy developed in Philadelphia has cleared a major regulatory hurdle, positioning it on an accelerated path toward approval in the United States and the …
FDA Fast-Track Boost Lifts iECURE Gene Therapy Toward Hope for Newborns Read More
WASHINGTON, D.C. — The Food and Drug Administration has released a congressionally mandated review of perfluoroalkyl and polyfluoroalkyl substances in cosmetic products, concluding that scientific evidence is too limited to …
FDA Finds Widespread PFAS in Cosmetics but Says Safety Data Falls Short Read More
PLYMOUTH MEETING, PA — INOVIO (NASDAQ: INO) said the U.S. Food and Drug Administration has accepted its Biologics License Application for INO-3107, a potential non-surgical treatment for adults with recurrent …
FDA Sets 2026 Decision Clock for INOVIO’s Rare Disease Therapy Read More
LANGHORNE, PA — Savara Inc. (Nasdaq: SVRA) said it has resubmitted its biologics license application for MOLBREEVI to the U.S. Food and Drug Administration, a key regulatory step toward approval …
FDA Clock Restarts: Savara Refiles MOLBREEVI for Rare Lung Disease Read More
WILMINGTON, DE — AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) said their jointly developed breast cancer therapy ENHERTU has received Breakthrough Therapy Designation from the U.S. Food and Drug …
ENHERTU Scores Tenth FDA Fast-Track as Breast Cancer Data Shifts Playbook Read More
PHILADELPHIA, PA — A husband-and-wife operation that claimed it could diagnose and cure cancer using so-called “smart chip technology” embedded in ultrasound machines has collapsed after both principals pleaded guilty …
Fake “Smart Chip” Cancer Scans Unraveled in Federal Fraud Guilty Pleas Read More
PHILADELPHIA, PA — GSK plc (LSE/NYSE: GSK) said the U.S. Food and Drug Administration has approved Exdensur, a twice-yearly biologic treatment for patients with severe asthma characterized by an eosinophilic …
FDA Clears GSK’s Twice-Yearly Asthma Drug, Signaling Shift in Biologic Care Read More 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