Keep track of the latest FDA approvals and regulatory changes impacting the biotech, medtech, and pharmaceutical sectors. Learn how new regulations are influencing healthcare innovation and access to groundbreaking treatments.
FDA’s “plausible mechanism” pathway transforms ultra-rare therapeutics; Siemens dramatically reduces Healthineers stake in €33.5B restructuring; gene editing platforms consolidate as capital rotates toward tools and
FDA unveils “plausible mechanism” approval route for ultra-rare therapies; gene editing biotechs restructure amid capital constraints; medtech delivers strong quarters; EU AI regulations tighten device
Richard Pazdur’s CDER appointment signals regulatory evolution; China’s biotech resurgence opens cross-border opportunities; medtech financing hits $26.6B as capital markets normalize The life sciences sector
Biotech opened the week navigating extreme regulatory volatility and clinical performance divergence. uniQure suffered a devastating 49% share collapse after the FDA reversed course on
Healthcare markets exploded with deal-making activity as November opened with a bang. Novartis dropped $12 billion to acquire Avidity Biosciences, Novo Nordisk and Pfizer escalated
Biotech delivered a sobering Halloween eve session as regulatory concerns collided with policy reforms and M&A speculation. Intellia Therapeutics’ CRISPR programs hit an FDA clinical
Monday delivered a mixed but ultimately positive session for healthcare investors, with strong pharmaceutical earnings and strategic deals offsetting concerns about biotech funding headwinds. Biopharma
The healthcare sector delivered a remarkable week of innovation, deal-making, and regulatory transformation. From the FDA’s groundbreaking National Priority Review program to over $6.4 billion
Markets experienced significant turbulence this week as banking sector concerns collided with healthcare earnings, policy developments, and robust deal-making activity. Here’s everything you need to
The final week of September brought seismic shifts across the pharmaceutical and biotechnology sectors, with an $8 billion oncology acquisition, leadership changes at Big Pharma
