Regulatory Approval

A major trial shows once-weekly rezafungin is as effective as daily drugs for preventing deadly fungal infections, heralding a new era for patient care.

The company's SEAL™ device, targeting complex wide-neck aneurysms, completes its final submission, backed by a major US clinical trial.

SECURE's board unanimously backs a $6.4B GFL merger, offering shareholders a 23% premium and a stake in a new North American waste management leader.

Top expert Dr. Henrik Zetterberg joins Circular Genomics, signaling a pivotal shift toward novel circular RNA blood tests for neurodegenerative disease.

Clinuvel's SCENESSE® advances to a pivotal Phase III trial with a novel EMA-backed design, focusing on patient experience and visible results.

A revolutionary organ preservation system is showing 100% graft survival in new studies, promising to expand the donor pool for children in need.

A medtech startup received a major NIH award to develop a wearable AI that predicts SUDEP, a deadly complication of epilepsy, offering new hope for patients.

Breakthrough trial data shows a new device can keep donor hearts viable for longer, potentially expanding the organ pool and saving thousands on waitlists.

A new AI-powered skin patch test for psoriasis just got a major US approval, promising to end costly trial-and-error treatments for millions of patients.

By achieving rigorous ONC certification, surgeon-developed 4D EMR is enhancing data security and interoperability for the unique needs of plastic surgery.

With rising cancer rates, Utepreva's innovative sampler promises more accurate and comfortable tissue collection, potentially transforming early diagnosis.

EXALTA Group's new ISO 17025 accreditation for its in-house lab aims to slash development time, reflecting a broader industry push for integrated partners.

A new drug for a life-threatening genetic heart condition begins late-stage trials, earning FDA Fast Track to potentially speed its path to patients.

Remix Therapeutics' first-in-class drug REM-422 targets a rare cancer at its genetic source, with pivotal data set for a major oncology conference.

New long-term data for FLT201 gene therapy could signal a paradigm shift from lifelong treatments for patients with Gaucher disease type 1.

Hyalex Orthopaedics’ new FDA-cleared Slalom™ implant, using cartilage-mimicking tech, offers a motion-preserving alternative to joint fusion.

A novel staple-like device from Inovedis gains expanded FDA approval, promising faster, less invasive repairs for a vast range of orthopedic injuries.

ProRx Pharma touts a major expansion to meet drug demand, but recent FDA warnings and massive recalls raise serious questions about its quality and safety.

AI promises to transform drug discovery, but billions in investment are at risk. A new report reveals why the real bottleneck isn't tech, but data itself.

With a new legal chief experienced in FDA clearance, Formedics signals an aggressive push to navigate regulatory hurdles and dominate HCP engagement.