Clinical
What Is a Medical Device Class I / II / III? Understanding FDA Device Classification
What Is a Medical Device Class I / II / III – Not all medical devices are created equal. A tongue depressor and an artificial
Key clinical trial readouts, study launches, safety data, design changes, and patient outcomes across Phase 1–3 programs in biotech, medtech, and pharma.
What Is a Medical Device Class I / II / III – Not all medical devices are created equal. A tongue depressor and an artificial
Clinical trials are the gold standard for proving a drug works. But they have limits. Trials enroll carefully selected patients, follow strict protocols, and run
Phase 3 is where everything is on the line. After years of preclinical research, Phase 1 safety testing, and Phase 2 proof of concept, a
Phase 1 answered the safety question. Phase 2 answers a far more consequential one: does this drug actually work? This is where drug development gets
Before any new drug reaches patients, it must survive a gauntlet of testing. Phase 1 clinical trials are where that journey begins in humans —
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 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
The FDA just delivered hope to families dealing with one of childhood’s most challenging rare diseases. In a groundbreaking decision, the agency has expanded access
Microbiome subsidiary faces workforce reduction following ulcerative colitis study setback, highlighting development risks in emerging therapeutic area Vedanta Biosciences, PureTech Health’s microbiome-focused subsidiary, announced workforce
Allogeneic CAR-T leader advances multiple trials with $302.6M cash position, diversifying beyond oncology into autoimmune applications Allogene Therapeutics reported strong financial positioning with $302.6 million