Regulatory Approval

With a PDUFA date set, Arcutis' ZORYVE could soon offer a once-daily, non-steroidal cream for infants, addressing a massive unmet need for families.

Valid8 Financial's move toward FedRAMP certification signals a major shift in how government agencies tackle financial crime. Here's why it matters.

Presage Technologies' new FDA-cleared app turns any phone into a vital signs monitor, offering it free to hospitals to democratize healthcare access.

Saol Therapeutics' NDA resubmission isn't just a second chance; it's a calculated maneuver signaling a new playbook for navigating the FDA in rare disease.

The FDA has fast-tracked mitapivat for sickle cell disease, offering new hope for patients. But a closer look reveals the high stakes of this strategy.

Aligos Therapeutics secures a key partnership and regulatory fast-track in China, signaling a major financial and clinical validation for its novel HBV drug.

With its first FDA clearance, Movmedix introduces a synthetic ligament used in 250,000+ global procedures. But can it win over a U.S. market wary of its history?

Vivos Inc. wins FDA approval for a human trial of RadioGel®, a targeted therapy that could offer new hope for patients with non-resectable thyroid cancer.

IceCure's ProSense™ is reshaping oncology in Brazil. A US FDA approval provided a critical tailwind, validating a less invasive future for cancer care.

Invivyd's COVID-19 drug PEMGARDA loses its emergency status, sparking a high-stakes race for full approval and raising fears of a looming gap in patient care.

After a Health Canada-mandated pause, LSL's Steri-Med is near full remediation. This is more than a fix—it’s a calculated play for North American market leadership.

Cerezen, a non-invasive device shown to reverse cognitive decline, has EU approval but remains in FDA limbo, raising questions about US patient access.

Circus SE's autonomous kitchens are coming to UAE high-rises. It's a bold leap for urban food security, but can robotic sustenance truly feed a city?

After a successful FIFA World Cup debut, ADI Predictstreet is expanding. We explore how Gibraltar's regulatory gambit and blockchain tech are creating a new global forecasting tool.

YD Bio is expanding its U.S. lab network, but the real story is its strategy: turning diagnostic tests into a vast data engine to power the future of cancer research.

After a legal challenge, Peter Ballantyne Cree Nation now backs Denison's flagship project, de-risking a major future source of global uranium supply.

With a federal green light, the Springpole mine promises jobs and gold, but its real test lies in meeting strict environmental and Indigenous partnership terms.

Advicenne's unlimited UK drug approval for Sibnayal® is a win for rare disease patients, but it's one piece in a high-stakes global strategy now targeting the US market.

After completing massive studies, the Utah firm is readying an FDA submission that could move gold-standard diagnostics from the lab to your local clinic.

STARMED secures a landmark FDA clearance for its thyroid RFA system, the first of its kind, promising a minimally invasive alternative to surgery.