Industry News
The latest medical device regulatory news, clinical trials, and market insights
FDA Grants Regulatory Approval for Cellular Therapy to Address Severe Aplastic Anemia
The U.S. Food and Drug Administration (FDA) has taken a landmark step by granting approval for Omisirge (omidubicel-onlv), a hematopoietic…
FDA Approves Augmentin XR under New Voucher Program to Boost Antibiotic Production
The U.S. Food and Drug Administration (FDA) has announced the first approval under the Commissioner’s National Priority Voucher (CNPV) pilot…
FDA Grants Historic Approval to Gene Therapy for Wiskott-Aldrich Syndrome
The U.S. Food and Drug Administration (FDA) has approved Waskyra (etuvetidigene autotemcel), marking a significant milestone as the first cell-based…
FDA Moves to Include Bemotrizinol in Sunscreen Formulations: A Regulatory Update
The U.S. Food and Drug Administration (FDA) announced a major step forward in sunscreen product development on December 13, 2025.…
FDA Authorizes Two New Oral Treatments for Gonorrhea, Marking a Regulatory Milestone
The U.S. Food and Drug Administration (FDA) has approved two novel oral therapies for gonorrhea, a significant milestone in addressing…
Urgent Recall: Hameln Pharma Ltd Issues Safety Notice for Clarithromycin 500mg Infusion Powder
Hameln Pharma Ltd has issued a Class 2 Medicines recall for specific batches of Clarithromycin 500 mg powder for concentrate…
FDA Highlights Nationwide Recall of ReBoost Nasal Spray Over Microbial Risks
MediNatura New Mexico, Inc. has issued a voluntary recall of one lot of ReBoost Nasal Spray across the United States…
WBD Merger Turbulence Sets New Market Dynamics Ahead of Sundance 2026
Meta description: The ongoing WBD merger battle signals slower deal activity and rising opportunities for independent players as Sundance 2026…
UnitedHealth’s $3.3B Amedisys Deal Clears Court with Record Healthcare Divestiture
The United States District Court for the District of Maryland has approved UnitedHealth Group’s $3.3 billion acquisition of Amedisys, subject…
High-Stakes Battle Over Warner Bros Discovery Signals Rising Consolidation Risks
Meta description: A bidding clash between Netflix and a rival media giant for Warner Bros Discovery draws attention to consolidation…
AI Hardware Startup Secures $475M Seed Funding at $4.5B Valuation
Meta description: AI hardware startup Unconventional AI lands $475M seed investment at a $4.5B valuation, attracting top-tier tech and venture…
Robotics and Automation M&A Surges in 2025 with Multi-Stage Capital Inflows
North America’s automation and robotics market posted record-breaking M&A activity in 2025, with capital flowing across all stages and strong…