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The U.S. Food and Drug Administration has issued a draft guidance intended to help drug developers validate new approach methodologies to be used instead of animal testing in drug development, and to bring safe, effective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,...
Antibiotics remain vital to modern medicine, yet the report by Newmarket Strategy, a Healthcare consultancy, warned that reliable access is under growing threat, with experts urging immediate policy reforms. Specifically, the report emphasised the growing threat to the sustainable European supply...
The U.S. Food and Drug Administration has announced significant action to make it faster and less costly to develop biosimilar medicines, which are lower-cost "generic" alternatives to biologic drugs that treat serious and chronic diseases. In a new draft guidance, the FDA proposes major updates to...
One in six laboratory-confirmed bacterial infections causing common infections in people worldwide in 2023 were resistant to antibiotic treatments, according to a new report by the World Health Organization.. Between 2018 and 2023, antibiotic resistance rose in more than 40 percent of the pathogen-antibiotic combinations monitored, with an average annual increase of 5-15 percent, says the report
SCYNEXIS (SCYX) Tuesday reported positive Phase 1 results for its next-generation triterpenoid antifungal for invasive fungal infections, SCY-247. SCY-247 was well tolerated, with only mild to moderate adverse events reported in the study, which involved 88 healthy participants.
President Donald Trump has announced that he will impose 100 percent tariff on imports of brand-name or patented pharmaceutical products from next month unless the drug manufacturing company establishes a production plant in the United States. "Starting October 1st, 2025, we will be imposing a 100%...
A new report from the Centers for Disease Control and Prevention highlights a dramatic increase in a dangerous type of drug-resistant bacteria called NDM-producing carbapenem-resistant Enterobacterales, or NDM-CRE. The report, titled 'Changes in Carbapenemase-Producing Carbapenem-Resistant Enterobacterales,...
May 01, 2026 15:54 ET Central banks dominated the economics news flow this week with almost all major ones announcing their latest policy decisions and many boosted expectations for a rate hike in June. In other news, several countries released the preliminary data for first quarter economic growth. In the U.S., comments by Fed Chair Jerome Powell were also in focus as his term ends this month.