The U.S. Food and Drug Administration has authorized Aletta, the first standalone robotic device that can draw blood from a patient's arm without hands-on operator intervention. The device is authorized for use in adults in outpatient settings and must be operated under the oversight of a supervisor trained in phlebotomy. One phlebotomist can oversee up to three Aletta devices at the same time,
The U.S. Food and Drug Administration has approved Orzeyful (oveporexton) tablets for the treatment of narcolepsy type 1 in adults. Orzeyful is the first medicine approved for narcolepsy type 1 as a complete disorder — addressing the full range of symptoms that define the condition — and the first...
The U.S. Food and Drug Administration has licensed Ezplaz Freeze Dried Plasma, making it the first freeze-dried plasma product licensed for use in the United States. Ezplaz is intended for transfusion in adult patients who need plasma and for whom other plasma products are not available. "Patients...
In a major international effort to evaluate potential treatments for Ebola disease due to Bundibugyo virus (BVD), the PARTNERS clinical trial has opened enrolment for patients in the Democratic Republic of the Congo. The PARTNERS (Platform Adaptive Randomised Trial for New and Repurposed Filovirus...
The U.S. Food and Drug Administration announced the selection of seven companies to participate in the FDA PreCheck Pilot Program, a new initiative designed to boost American global competitiveness, strengthen domestic drug manufacturing, and improve the resilience of the U.S. drug supply chain. The...
The White House says the Trump Administration's Most-Favored-Nation (MFN) drug pricing policy framework to address the major differences in drug prices and contributions to the pharmaceutical innovation enterprise across developed countries is expected to generate $529 billion in domestic savings in the next 10 years across all markets. The Trump Administration has so far reached voluntary MFN pr
The U.S. Food and Drug Administration has announced that vit achieved its key first-year goals in the implementation of its April 2025 Roadmap to Reducing Animal Testing in Preclinical Safety Studies, marking one year of transformative action to modernize drug development through innovative, human-relevant...
The U.S. Food and Drug Administration has reminded more than 2,200 medical product companies and researchers of the requirements to submit certain clinical trial results information to ClinicalTrials.gov. Companies and researchers often fail to disclose negative trial results, resulting in significant...
C4 Therapeutics (CCCC) has entered into a new collaboration agreement with Roche (RHHBY, RO.SW, ROG.SW) to advance research in the degrader-antibody conjugate or DAC, modality. C4 Therapeutics and Roche will collaborate on two programs to develop DACs against undisclosed oncology targets exclusive to...
Climb Bio, Inc. (CLYM), Tuesday announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to budoprutug for the treatment of primary membranous nephropathy, a rare kidney disease. The company believes that the designation would accelerate the budoprutug development...
The U.S. Food and Drug Administration has issued a draft guidance intended to help drug developers validate new approach methodologies to be used instead of animal testing in drug development, and to bring safe, effective drugs to market sooner based on human-centric data. This marks another major...
The U.S. Food and Drug Administration has approved Waskyra (etuvetidigene autotemcel), the first cell-based gene therapy for the treatment of a rare, genetic immune disorder Wiskott-Aldrich syndrome, or WAS. Waskyra is indicated for pediatric patients six months and older and adults with WAS who...
The U.S. Food and Drug Administration has approved Augmentin XR (amoxicillin-clavulanate potassium) under the Commissioner's National Priority Voucher pilot program, marking the first approval achieved through this review pathway. The approval was completed in just two months, representing a major reduction of the review timeline for this type of application. "Over the last few decades, America l
The U.S. Food and Drug Administration announced that it has approved Omisirge (omidubicel-onlv), the first hematopoietic stem cell transplant (HSCT) therapy to treat patients with severe aplastic anemia (SAA). Omisirge is indicated for adults and pediatric patients 12 years and older with hematologic...
The Office of the United States Trade Representative, the Department of Commerce, and the Department of Health and Human Services have announced that the U.S. Government has reached an agreement in principle on pharmaceutical pricing with the United Kingdom. In the U.S.-U.K. Economic Prosperity Deal,...
August 21, 2026 14:42 ET The minutes of the latest policy meeting of the Federal Reserve, housing market data and manufacturing sector survey results were the main news for the U.S. economy this week. In Europe, inflation data from the U.K. was the highlight, while consumer price data from Japan drew attention in Asia.