Gene therapy has moved from experimental promise to clinical reality. Over the past few years, regulatory approvals have validated decades of research, transforming once-fatal genetic disorders into treatable conditions. But

Opening: Regulation as a Strategic Lever, Not a Barrier For biotech founders, regulation is no longer just a box to check at the end of development—it is a strategic force

Introduction: From Discovery to Design Biotechnology is entering a defining era, one where biology is no longer only studied, but increasingly designed. Advances in gene editing and synthetic biology are

Introduction: Regulation Becomes a Strategic Force As biotechnology accelerates from gene editing and synthetic biology to AI-driven drug discovery regulation is no longer a background consideration. In 2026, policy frameworks

When a mother in Bengaluru posted a tearful message after her child with an ultra, rare genetic disorder gained access to a customised gene therapy approved via the Food and

Innovation is sprinting ahead. Regulators are scrambling to keep up , and rewrite the playbook on the fly. A Race Against Time Imagine a child born with a rare genetic

When Deadlines Loom: Regulation Shifts You Can’t Ignore in Biotech & Health It was 10:45 pm on a Thursday when Maya raced to her laptop. She had promised her team