Miamisburg-based Riverain Technologies receives FDA clearance for AI-powered imaging software
A Dayton-area medical technology firm has recently had its AI-driven image processing and analysis technology cleared by the ...
CURE6h
Breaking Down the FDA Labeling Update of Xeloda and 5-FU in Cancer Care
The FDA has updated the product labeling for Xeloda and 5-FU to highlight the risks associated with dihydropyrimidine ...
Managed Healthcare Executive7h
FDA Approves Combination Antibiotic for Complicated Infections
Emblaveo will be available in the third quarter of 2025 to treat patients with intra-abdominal infections, a common cause of sepsis in the intensive care unit.
Targeted Oncology4d
FDA Grants Key Oncology Approvals and Designations in January 2025
On January 7, 2025, the FDA granted priority review to the new drug application for sunvozertinib (DZD9008), an oral EGFR ...
Cautious On Arrowhead Pharmaceuticals' FDA NDA Acceptance Due To Valuation Concerns
Arrowhead Pharmaceuticals recently received the FDA NDA acceptance for Plozasiran. Read why I believe ARWR stock could be a ...
Food Safety News22h
FDA warns two companies over foreign supplier verification violations
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...
dvm3604d
FDA notifies veterinarians of animal burn risk linked to human medical devices
Following a recall of grounding pads produced by Megadyne, a machinery industry company, the FDA is notifying veterinarians ...
PharmExec5d
FDA Grants Fast Track Designation to Adicet Bio’s CAR T-cell Therapy for Systemic Lupus Erythematosus
The FDA has granted Fast Track Designation to Adicet Bio’s ADI-001, an allogeneic gamma delta CAR T-cell therapy, for ...
Updated drug information handout outdoes FDA's version in clinical trial
A clinical trial comparing a one-page medication handout proposed by the U.S. Food and Drug Administration (FDA) with an ...
CURE5d
FDA-Approved Calquence Combo Is First and Only of Its Kind in MCL
Dr. Tycel Phillips discusses the FDA approval of a Calquence combo in MCL, making it the first and only BTK inhibitor ...
The American Journal of Managed Care6d
FDA Approves Ranibizumab Implant in Treatment of DME
The ranibizumab injection delivered through an implant device could be administered in a convenient schedule twice per year ...
The American Journal of Managed Care6d
FDA Approves First Subcutaneous Apomorphine Device for Parkinson Disease
The FDA has approved the first and only subcutaneous apomorphine infusion device, apomorphine hydrochloride injection (Onapgo ...