The FDA just dropped draft recommendations that could fundamentally change how cell and gene therapies (CGT) get developed and approved. The new guidelines emphasize adaptive
The shift from intravenous to subcutaneous drug administration is accelerating across oncology and immunology, fundamentally changing how patients receive treatment and how healthcare systems manage
The gene therapy space just got a massive validation with uniQure’s AMT-130 delivering unprecedented results in Huntington’s disease. Three-year data showing approximately 75% slowdown in
The United States has initiated Section 232 national security investigations into imports of medical equipment, personal protective equipment (PPE), and medical devices, sending shockwaves through
After more than half a year without a sizable biotech IPO, LB Pharmaceuticals just raised $285 million in an upsized Nasdaq offering. For an industry
The FDA just released guidance aimed at accelerating non-opioid pain treatment development, and it could be a game changer for companies working on novel analgesics.
The CDC’s Advisory Committee on Immunization Practices just voted unanimously to change how we think about COVID vaccination. Instead of universal booster recommendations, they’re now
Merck just scored FDA approval for Keytruda QLEX, a subcutaneous formulation of pembrolizumab that can be administered in 1-2 minutes instead of a 30-minute IV
The obesity drug market is heating up fast, and Pfizer just made a major play. Their acquisition of Metsera for up to $7.3 billion shows
The World Health Organization just made a decision that could reshape global access to some of the world’s most sought-after medications. By adding GLP-1 receptor
