Celltrion’s YUFLYMA® Secures Full FDA Interchangeability Status Across All Approved Forms and Strengths, Reinforcing Market Leadership and Commitment to Affordable Biologics Celltrion, Inc., a global biopharmaceutical company headquartered in South Korea, announced a significant regulatory milestone with the U.S. Food…
Grifols Secures FDA Clearance to Advance Immunoglobulin Eye Drops into Phase 2 Trial for Dry Eye Disease Grifols, a global leader in the production of plasma-derived medicines and a prominent name in the healthcare sector, has taken a pivotal step…
Merck and imec Forge Strategic Alliance to Revolutionize Drug Discovery Through Advanced Microphysiological Systems Merck, a global leader in science and technology, and imec, a premier international hub for research and innovation in nanoelectronics and digital technologies, have announced a…
Roche Provides Update on FDA Advisory Committee Review of Columvi Combination Therapy for Relapsed or Refractory DLBCL Roche has shared an important regulatory update concerning its investigational treatment for a particularly aggressive form of blood cancer. On May 21, 2025,…
FDA Grants Limited Approval to Novavax COVID-19 Vaccine Amid Signs of Upcoming Changes to Vaccine Approval Process The recent decision by the U.S. Food and Drug Administration (FDA) to grant a narrowly tailored approval for Novavax’s COVID-19 vaccine, Nuvaxovid, is…
GSK Secures Japanese Approval for Blenrep Combinations in Relapsed/Refractory Multiple Myeloma Based on Robust Phase III Data In a major advancement for the treatment landscape of multiple myeloma, GSK plc (LSE/NYSE: GSK) announced that Japan’s Ministry of Health, Labour and…
Regeneron to Acquire Core Assets of 23andMe for $256 Million in Bankruptcy Auction, Pledges to Preserve Consumer Genetics Mission and Strengthen Human Health Research In a major development within the biotechnology and genetics sectors, Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) has…
BATURA Phase IIIb Trial Establishes Airsupra as a New Standard for As-Needed Asthma Rescue Treatment AstraZeneca has released the full results from its pivotal BATURA Phase IIIb trial, revealing that the anti-inflammatory rescue therapy Airsupra (a fixed-dose combination of albuterol…
Cytokinetics Issues Equity Awards as Employment Inducements Under Nasdaq Rule 5635(c)(4), Advances Momentum in Cardiovascular Drug Development Cytokinetics, Incorporated (Nasdaq: CYTK), a leading biopharmaceutical company dedicated to developing novel therapies for cardiovascular and neuromuscular diseases, announced today that it has…
Merck to Present Robust Set of Pulmonary Arterial Hypertension Data at ATS 2025, Underscoring Long-Term Commitment to Innovation and Patient Outcomes Merck , known as MSD outside the United States and Canada, has announced that it will present a wide-ranging…
Leadership Transition at Novo Nordisk: CEO Lars Fruergaard Jørgensen to Step Down Amid Market Headwinds and Strategic Realignment In a significant leadership transition, Novo Nordisk A/S announced that Lars Fruergaard Jørgensen, the company’s longstanding Chief Executive Officer, will step down…
Incyte Announces FDA Approval of Zynyz® (retifanlimab-dlwr), the First and Only Approved First-Line Treatment for Advanced Anal Cancer in the U.S. Incyte Corporation (Nasdaq: INCY), a global biopharmaceutical company focused on delivering innovative therapies for patients with serious diseases, today…