Chester County News and Community Website
TELFORD, PA — Draeger, Inc. has received U.S. Food and Drug Administration clearance for new software enhancements to its Evita V800 ventilator, adding features designed to support the treatment of …
FDA Clears New Draeger Ventilator Features for Lung Disease Care Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration has proposed requiring foreign tobacco manufacturers to register their facilities and disclose detailed product information, a move aimed at strengthening enforcement …
FDA Proposes Rule to Expand Oversight of Foreign Tobacco Products Read More
WAYNE, PA — Palvella Therapeutics (Nasdaq: PVLA) has received U.S. Food and Drug Administration authorization for rolling review of its New Drug Application for QTORIN rapamycin, a step that could …
Palvella Secures FDA Rolling Review for Rare Disease Drug Read More
WILMINGTON, DE — NRx Pharmaceuticals (Nasdaq: NRXP) said the U.S. Food and Drug Administration has authorized an Expanded Access Protocol for its investigational depression treatment NRX-101, potentially allowing certain patients …
FDA Clears Expanded Access Path for NRx Depression Therapy Read More
PHILADELPHIA, PA — GSK (LSE: GSK; NYSE: GSK) and Spero Therapeutics (Nasdaq: SPRO) said the U.S. Food and Drug Administration has approved Utebzi, the first oral carbapenem antibiotic for adults …
FDA Clears GSK Antibiotic for Drug-Resistant UTI Patients Read More
WASHINGTON, D.C. — The Food and Drug Administration is seeking revisions to prescribing information for testosterone replacement therapies after concluding that newer clinical evidence no longer supports certain longstanding restrictions …
FDA Seeks Testosterone Label Changes After Evidence Review Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration has approved the first generic version of Xofluza (baloxavir marboxil), expanding access to a single-dose influenza treatment and prevention option ahead …
FDA Clears First Generic Xofluza Ahead of Flu Season Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration has expanded the approved use of Tzield (teplizumab) to children ages 8 to 17 who have been recently diagnosed with Stage …
FDA Expands Tzield Use for Children With Type 1 Diabetes Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration has approved Rextovy, an over-the-counter naloxone nasal spray for emergency treatment of opioid overdoses, expanding consumer access to a medication widely …
FDA Approves OTC Naloxone Spray, Expanding Overdose Access Read More
WILMINGTON, DE — AstraZeneca’s TRUQAP (capivasertib) has won U.S. approval for a subset of patients with advanced prostate cancer, providing the first biomarker-targeted treatment option for an aggressive form of …
FDA Clears AstraZeneca Prostate Cancer Therapy for PTEN Patients Read More