FDA’s Orphan Drug Leadership Shifts Amid Policy Changes and Department-Wide Shakeups Sandra Retzky, formerly the top orphan drug regulator at the FDA, is no longer serving as director of the Office of Orphan Products Development. The departure, first reported by…
AbbVie Announces FDA Approval of Updated RINVOQ® (upadacitinib) Indication for Inflammatory Bowel Disease NORTH CHICAGO, Ill., Oct. 13, 2025 /PRNewswire/ – AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug…
BeOne Medicines’ Sonrotoclax Granted Breakthrough Therapy Designation by U.S. FDA, Set to Participate in Project Orbis BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA)…
Regeneron Presents Latest DB-OTO Data Showing Dramatic and Sustained Hearing and Speech Improvements in Children with Profound Genetic Hearing Loss Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced updated data for its investigational gene therapy DB-OTO for profound genetic hearing loss…
AstraZeneca Showcases Transformative Oncology Pipeline with Breakthrough Data Across Multiple Cancer Types at ESMO 2025 AstraZeneca has reaffirmed its leadership in oncology innovation at the upcoming European Society for Medical Oncology (ESMO) Congress 2025, set to take place from October…
Roche to Present Over 30 Oncology Abstracts at ESMO 2025, Showcasing Breakthroughs Across Major Cancer Types Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that it will present more than 30 scientific abstracts spanning over 10 cancer types at the European…
Innate Pharma to Host Analyst and Investor Event Highlighting Lacutamab Clinical Data and Market Potential on October 28, 2025 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA), a clinical-stage biopharmaceutical company focused on innovative immuno-oncology therapies, announced today that it…
Zoetis Receives Positive CVMP Opinion for Lenivia®, a Novel Therapy to Reduce Osteoarthritis Pain in Dogs Zoetis Inc., a global leader in animal health, today announced that the Committee for Veterinary Medicinal Products (CVMP) of the European Medicines Agency (EMA)…
Satellos Bioscience Reports Promising Safety, Tolerability, and Functional Benefits of SAT-3247 in Adults with Duchenne Muscular Dystrophy Satellos Bioscience Inc. (TSX: MSCL, OTCQB: MSCLF), a clinical-stage biotechnology company focused on developing transformative therapies for degenerative muscle diseases, has unveiled new…
Prilenia and Ferrer Highlight Compelling New Evidence of Pridopidine’s Disease-Modifying Potential in Huntington’s Disease at the 2025 HSG Congress Prilenia Therapeutics B.V. and Ferrer have jointly announced the presentation of five new scientific posters at the 2025 Huntington Study Group…
Bristol Myers Squibb Expands and Diversifies RNA and Cell Therapy Portfolio Through Acquisition of Orbital Therapeutics Bristol Myers Squibb (NYSE: BMY) announced a significant strategic move to strengthen its leadership in the field of cell and gene therapy with the…
AstraZeneca Expands U.S. Manufacturing Footprint with $4.5 Billion Virginia Facility, Creating 3,600 Jobs and Advancing Domestic Biopharmaceutical Production AstraZeneca has announced an expanded commitment to U.S. manufacturing with a $4.5 billion investment in a new state-of-the-art production facility in Virginia,…