Regulatory Approval

MIC Global and Qatar Insurance (QIC) partner to launch MiIncome, an embedded insurance product aimed at closing the region's critical income protection gap.

Guerbet's Elucirem™ gains FDA approval for patients aged 0-2, halving gadolinium exposure in the most vulnerable without sacrificing diagnostic quality.

A new virotherapy platform delivers a one-two punch of a T-cell activator and a BiTE, aiming to overcome historical failures in solid tumor therapy.

Following massive asset sales and billions in dividends, Array Digital reports surging tower revenue and an optimistic forecast for its new 5G future.

The biotech firm landed $1M at a premium, a sign of investor faith. But with past regulatory hurdles, can this cash pave a new path for its NurOwn® therapy?

MAIA Pharmaceuticals will bring Teribone™, a proven therapy used in Japan, to the US, aiming to solve the critical patient adherence crisis in osteoporosis care.

As argenx prepares its full-year 2025 update, investors are watching if the VYVGART sales boom can fund a pipeline aimed at dominating autoimmune care.

New Midas and Pro 2 capabilities promise to bring complex, multi-unit restorations and custom preventive care into a single patient visit.

After two decades of global use, Fziomed's anti-adhesion gel has treated one million patients, signaling a major shift in post-surgical recovery.

A new patent-pending AI platform from Montreal's E-Biotech promises to streamline GMP compliance by integrating with, not replacing, existing systems.

Sprott Physical Copper Trust plans monthly redemptions and a US market entry, aiming to boost liquidity as global demand for the critical metal soars.

As Adagene presents at key conferences, its SAFEbody tech and lead drug muzastotug draw focus amid a strategic push for funding and partnerships.

Annexon Biosciences spotlights its novel C1q inhibitor, Vonaprument, aiming to be the first therapy to preserve vision in geographic atrophy patients.

NRx Pharmaceuticals gets a green light from the FDA to seek broader approval for its ketamine drug, NRX-100, using a novel real-world evidence approach.

A new therapy for a rare brain cancer is one step closer to patients after the FDA accepted tirabrutinib for accelerated review, offering hope where few options exist.

With a bolstered cash runway from recent funding, Inventiva is all-in on its MASH drug, lanifibranor, racing against giants in a multi-billion dollar market.

Zemcelpro® gains key reimbursement status, offering immediate hope and access for German patients with limited options and paving a new path for cell therapy.

LEX Diagnostics' newly FDA-cleared VELO system delivers lab-quality PCR results for flu & COVID in under 10 minutes, set to revolutionize point-of-care testing.

A landmark trial for Roche’s Gazyva shows unprecedented success in treating primary membranous nephropathy, offering hope of preventing kidney failure.

CenterWell's major acquisition of MaxHealth adds 82 clinics and 120,000 patients, deepening its hold on Florida's value-based senior care sector.