The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has unveiled an innovative Early Access program that will allow certain high-priority medical devices to enter
HistoSonics has secured a transformative investment that values the innovative medical device company at $2.25 billion, with a consortium led by Johnson & Johnson Development
The Federal Trade Commission has filed a lawsuit to prevent Edwards Lifesciences from completing its $945 million acquisition of JenaValve Technology, marking a significant regulatory
Strand Therapeutics has raised an impressive $153 million in funding to advance its pioneering programmable mRNA cancer therapy platform, with backing from pharmaceutical giants Amgen
The FDA has unveiled its ambitious PreCheck program, a strategic initiative designed to fast-track the regulatory review of pharmaceutical manufacturing facilities and strengthen America’s domestic
Jazz Pharmaceuticals has achieved a groundbreaking milestone in pediatric oncology with the FDA approval of Modeyso (vorasidenib), marking the first systemic treatment specifically approved for
Eli Lilly’s highly anticipated oral obesity treatment orforglipron delivered solid but underwhelming results in its Phase 3 trial, triggering a dramatic market reaction that wiped
The Ruling’s Ripple Effect for SDK-Based Data Harvesting in Digital Health A landmark court ruling finding Meta liable for improperly collecting sensitive reproductive health data
Implications for Future Pandemic Readiness and Platform Vaccine Funding The Department of Health and Human Services’ decision to terminate multiple pandemic-era mRNA vaccine development programs
Strategic Leaning in a Capital-Conscious Biotech Environment Flagship Pioneering’s Alltrna has made the unusual decision to trim its workforce ahead of dosing its first patient
