Regulatory Approval

The FDA is betting on AI to manage chronic illness. Cadence's new pilot for its hypertension software could rewrite the rules for digital health regulation.

Rigel's VEPPANU is the first FDA-approved PROTAC, a new class of drug that destroys disease proteins. This is the story behind the science and the numbers.

BioCardia secures key regulatory backing in the US and Japan, but the real story may be its pivot to a platform provider for the entire cardiac biologics field.

With an October FDA deadline for its lead drug, INOVIO walks a financial tightrope, betting its future on a first-in-class treatment and a broader DNA platform.

A Chinese firm's historic USFDA approval for a complex generic drug ingredient signals a major shift in the global pharma supply chain and promises cheaper medicines.

With new SEC and FINRA approvals, Copper isn't just launching a service; it's laying down the compliant plumbing for institutional digital finance.

A new study shows 98% success for Mendaera's handheld robot. Beyond the launch, can this device truly bridge the gap in specialized medical skills?

A traditional construction firm is set to become a pure-play AI robotics company on the NYSE. Why is JFB betting it all on XTEND's autonomous technology?

With FDA clearance for its AI burn scanner, Spectral AI faces its next test: conquering the market. Can it turn government contracts into commercial success?

A pivotal ATF ruling reclassifies the BolaWrap as a restraint tool, not a weapon. This opens a vast private market, but as the tool expands beyond police, new questions of oversight arise.

The new-age power derivatives exchange gets a regulatory green light to bring in traditional brokers, a move set to deepen liquidity and reshape energy hedging.

A massive luxury development in Cabo Rojo promises jobs and green innovation, but locals fear it's a mirage that will consume vital resources and displace communities.

Quebec's funding for Roche's Itovebi offers new hope for breast cancer patients, but its complex approval reveals a national struggle over drug costs and access.

Datasea secured a key FDA listing for its AI-powered NeuroVibe system, a step toward US sales. But 'listing' isn't 'approval.' Here's the real story.

A court ruling clears a path for a massive potash mine in the Amazon, promising fertilizer independence for Brazil but igniting fierce opposition from Indigenous groups.

Sirion's top-tier IRAP security clearance in Australia is more than compliance; it's a strategic key to a lucrative market and a new benchmark for trust in AI.

As Johnson & Johnson prepares for a key investor conference, its strategy hinges on a potent mix of new drugs, robotic surgery, and a leaner focus.

With a strong cash runway, Nkarta pushes its off-the-shelf NK cell therapy into community clinics, setting the stage for a pivotal data reveal in 2026.

Insight Molecular Diagnostics has key regulatory and reimbursement wins for its game-changing transplant test, but a high cash burn creates a high-stakes race to commercialization.

Strong Attruby sales and new data showing superiority fuel BridgeBio’s momentum as it prepares for three FDA decisions, backed by a new $1B financing.