Regulatory Approval

With the appointment of Kelly Johnston McKee, Science 37 signals a major push to redefine patient experience and operationalize the future of clinical research.

ENNOVI's Tijuana expansion offers a key nearshoring solution for medical device makers, tackling complex regulations and streamlining North American supply chains.

China approves Libevitug, a first-in-class drug for the most severe form of hepatitis, marking a major milestone for patients and global biotech innovation.

Myra Vision's Calibreye system, the first adjustable glaucoma shunt, has been implanted in a US patient, offering hope for personalized vision-saving therapy.

A new intelligent oral appliance using biofeedback shows a massive reduction in sleep bruxism, offering hope to millions who suffer from jaw pain and headaches.

Following impressive Phase 2 results, Scancell's novel immunotherapy iSCIB1+ receives FDA clearance for a pivotal trial, offering new hope for patients.

Acrivon Therapeutics to unveil pivotal data showing high response rates for its targeted drug ACR-368 in an aggressive endometrial cancer subtype.

Swedish biotech innovator Hansa Biopharma wins a top award for its life-saving transplant tech, facing a pivotal year with FDA review on the horizon.

An investigational drug from Veloxis Pharmaceuticals has received a key FDA designation, offering new hope for liver transplant patients facing lifelong toxic therapies.

Health Canada acknowledges PetVivo's innovative Spryng joint treatment, paving the way for a new option for aging pets and athletic animals in Canada.

With $35.1M in new funding, Infinitopes is launching a human trial for its AI-designed vaccine aimed at preventing oesophageal cancer recurrence.

A breakthrough liquid biopsy using '6-base genome' analysis shows unprecedented success in spotting Stage I colorectal cancer, promising to boost survival rates.

The NYSE unveils a plan for a blockchain-based trading platform, promising 24/7 operations and instant settlement in a landmark move for digital assets.

As dementia rates soar, one AI firm is using subtle signals from speech and drawing to spot cognitive decline years earlier, moving healthcare toward prevention.

A first-in-class immunotherapy, UNLOXCYT™, offers a new lifeline for patients with advanced skin cancer, made accessible through a key national partnership.

Alexis Rodriguez rises to VP of Strategy, leveraging a unique engineering and finance background to guide Essential's aggressive expansion and a looming mega-merger.

Results in Nature Medicine reveal an immunotherapy that may stop cancer before it starts in high-risk Lynch Syndrome carriers, heralding a new era of prevention.

Cardiac Biotech Solutions partners with a local firm to launch its MyCardia AT monitor in China's booming, nearly $3 billion cardiac device market.

Willow Labs' new Nutu app combines AI coaching with CDC-backed standards, offering a smarter, evidence-based path to lasting metabolic health.

Adial Pharmaceuticals files a key patent to protect its personalized Alcohol Use Disorder drug, AD04, until 2045, signaling a new era for addiction medicine.