FDA Under Makary Eyes New Pathway for Rare Disease Drugs Amid Debate Over Feasibility and Safety While the U.S. Food and Drug Administration (FDA) under new Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. may seem a far…
FDA and NIH Push Toward Replacing Animal Testing with AI and Human Organoids In a groundbreaking move, the FDA—under Commissioner Marty Makary—announced plans in April to significantly reduce animal testing requirements for monoclonal antibodies and other therapies. The agency aims…
Why Deregulation Won’t Deliver for the Pharmaceutical Industry The current U.S. presidential administration under Donald Trump has begun eliminating federal regulatory staff and announced plans to dramatically scale back regulations. While administration figures like senior advisor Elon Musk and U.S.…
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Society for Science proudly announced the winners of the 75th Regeneron International Science and Engineering Fair (Regeneron ISEF), the world’s largest pre-college STEM competition. The event brought together nearly 1,700 young innovators from 48…
Novo Nordisk has announced significant leadership changes, including the upcoming departure of CEO Lars Fruergaard Jørgensen. As part of a mutual agreement with the Novo Nordisk Board of Directors, Jørgensen will step down from his role, though he will continue…
As the FDA gears up for a jam-packed Oncologic Drugs Advisory Committee (ODAC) meeting next week, internal sources are raising concerns about the agency’s preparedness. According to an FDA insider who spoke with BioSpace on condition of anonymity, staffing challenges…
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced a significant legal victory after a jury in the U.S. District Court for the District of Delaware ruled that Amgen Inc. violated multiple antitrust and tort laws. The jury found that Amgen unlawfully leveraged…
Novartis is set to unveil data from 60 company- and investigator-sponsored abstracts at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and the European Hematology Association (EHA) Congress. These presentations spotlight advances that could reshape clinical practice across…
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today reported that its Phase 3 KEYNOTE-B96 trial (ENGOT-ov65) has met its primary endpoint, showing a statistically significant improvement in progression-free survival (PFS) for patients with platinum-resistant recurrent…
Shockwave Medical, Inc., now part of Johnson & Johnson MedTech and a global leader in circulatory restoration, announced today that it will showcase data from 23 company-sponsored studies—including three late-breaking presentations—at EuroPCR 2025, taking place from May 20–23 in Paris.…
Central Iowa Shelter & Services (CISS), in partnership with Iowa Total Care, will hold a ribbon cutting ceremony to unveil the new Empowerment Command Center and Affordable Housing Project on Wednesday, May 21 at 11:00 a.m. The event will take…
Meridian, a provider of government-sponsored managed care services and a Centene company (NYSE: CNC), announced today the continuation and expansion of its health equity efforts through partnerships with farmers markets across central and southern Illinois in 2025. This initiative aims…