Regulatory Approval

With backing from a top hospital, VolitionRx seeks reimbursement for its Nu.Q® blood test, aiming to transform lung cancer care in France and beyond.

After a regulatory setback, Ultragenyx has resubmitted its BLA for UX111, a potential first-ever treatment for the devastating Sanfilippo syndrome type A.

Ruxolitinib cream's landmark approval in China marks a new era for vitiligo treatment, impacting patients, markets, and regulatory policy.

A major real-world study shows physician-led medical cannabis use improves pain, anxiety, and quality of life, adding key evidence to the field.

CIRM's new RAPID program aims to revolutionize genetic therapy, using scalable platforms to bring hope to millions with rare diseases who have no options.

A $10M investment from pharma giant Dr. Reddy’s validates Coya Therapeutics' novel ALS drug, funding the path to commercial-scale manufacturing.

A new dual-action tablet shows major promise for prostate cancer patients with BRCA mutations, poised to change the standard of care in Europe.

The market for drugs like Ozempic and Wegovy is set to explode, fueled by new oral pills, expanded uses for heart and liver disease, and fierce competition.

Quetzal Therapeutics’ oral capsule for a rare leukemia could replace grueling IVs. The FDA's Fast Track status signals a major shift for patients and investors.

A novel, dissolvable microsphere for chronic pain gets the green light in Canada, paving the way for a North American market entry and a new era in pain management.

A landmark study validates Panakeia's AI, which provides critical cancer biomarker results in minutes, promising to revolutionize patient care globally.

The FDA has qualified MolecuLightDX's measurement tool, a move set to standardize clinical trials, accelerate innovation, and redefine wound healing.

With new board members from J&J MedTech and key VCs, the firm is set to scale its real-time AI-powered tissue imaging platform for cancer diagnostics.

The Spanish pharma giant secures approval for the first oral antibiotic specifically for acne in China, targeting a multi-billion dollar dermatology market.

Robotics pioneer Wandercraft adds med-tech veteran Chuck Witkowski to its board, a strategic move to commercialize its Eve exoskeleton and scale globally.

A new medical device enters real-world trials, promising to solve a critical failure point in dialysis grafts and improve life for millions of patients.

A landmark FDA decision allows Life Biosciences to test its epigenetic reprogramming therapy, ER-100, offering new hope for restoring sight in the blind.

As drug-resistant fungi pose a grave threat, SCYNEXIS presents promising data on SCY-247, a next-gen drug that could redefine the fight against infection.

Finnish firm GlucoModicum publishes research validating its needle-free tech, a major step toward ending painful finger pricks for diabetes management.

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