AstraZeneca Showcases Oncology Breakthroughs at ASCO 2025, Reinforcing Mission to Eliminate Cancer as a Cause of Death AstraZeneca will present new data from over 80 abstracts at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (May 30 –…
Roche Presents Positive ODAC Discussion on Columvi® Combination Therapy for Aggressive Lymphoma Basel, Switzerland – May 21, 2025 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) held…
Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that additional data arising from two analyses from SEQUOIA-HCM, (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM), the pivotal Phase 3 clinical trial of aficamten in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM), and results from a real-world analysis related to…
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…