Medical Device and Pharmaceutical News
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FDA Grants Accelerated Approval to Tarlatamab-dlle
Treatment for lung cancer with progression following platinum-based chemotherapy On May 16, 2024, the Food and Drug Administration (FDA) granted accelerated approval to Imdelltra (tarlatamab-dlle) manufactured by Amgen, Inc. for the treatment of extensive stage small...
FDA Approves New Imaging Drug Lumisight
A Significant Improvement for Surgical Oncology The U.S. Food and Drug Administration (FDA) has granted approval to LumiSight (pegulicianine) for use in adults undergoing breast lumpectomy, marking a significant advancement in surgical oncology. Lumisight, a...
FDA Issues Warning on Counterfeit Botox Products
Real Botox PackagingReal Botox Cosmetic PackagingReal Botox PackagingCounterfeit Botox Products The U.S. Food and Drug Administration (FDA) has issued a critical alert concerning the presence of counterfeit Botox products in various states, posing severe risks to...
FDA Approves XACT Carotid Stent System
A Breakthrough for Stroke Prevention Abbott Vascular Inc. has received FDA approval for its groundbreaking XACT Carotid Stent System, a significant advancement in stroke prevention technology. Approved on February 7, 2024, this innovative system offers new hope for...
FDA Approves Xolremdi for WHIM Syndrome
A Breakthrough for Rare Infections In a groundbreaking development, the U.S. Food and Drug Administration (FDA) has granted approval for Xolremdi (mavorixafor) capsules, marking a significant milestone in the treatment of WHIM syndrome. Let's delve into what this...
FDA Fast Track Program
For Serious Conditions - Unmet Medical Needs The FDA's Fast Track program is designed to facilitate the development and expedite the review of drugs and biologics intended to treat serious conditions and fill an unmet medical need. Following are key details of the...
FDA’s Orphan Drug Program
Expedite Development of New Orphan Drugs The FDA's Orphan Drug Program is designed to encourage the development of drugs and biologics for the treatment, diagnosis, or prevention of rare diseases or conditions, often referred to as orphan diseases. Here are the key...
Rare Pediatric Disease Priority Review Voucher program
Expedite Development of New Pediatric Drugs The legislation for priority review of rare pediatric diseases is intended to expedite the development and approval of drugs for serious or life-threatening conditions affecting children. A summary of program and its key...
Key FDA Congressional Legislation
Several significant congressional legislative actions have directly affected the establishment, oversight authority, and processes of the US Food and Drug Administration (FDA). As a component of professional regulatory competencies, it is important for a regulatory...
Medical Devices and Pharmaceuticals
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