Regulatory Approval

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.

Cyclerion's novel therapy for treatment-resistant depression, using EEG-guided anesthesia, gains key FDA support and a top-tier advisory board.

With a key depression drug nearing Phase 3 and more data imminent, AtaiBeckley is set to make its case to Wall Street at three major March conferences.

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.

Landmark Phase 3 trial results show psilocybin offers rapid, lasting relief for severe depression, pushing psychedelic medicine closer to the mainstream.

Oculis appoints former Cooley partner Katie Kazem as CLO, a strategic move to fortify governance ahead of pivotal data readouts for its late-stage eye drugs.

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.

A record-breaking drone and air taxi display at the Spring Festival Gala was more than a show; it was a bold statement on China's low-altitude economy.

After a costly regulatory exit, crypto giant Nexo plans a 2026 U.S. return, partnering with Bakkt in a bid to redefine compliant digital finance.

A new genomics tracker reveals the fragmented adoption of precision cancer care across the EU-5, highlighting critical barriers and strategic opportunities.

Linkhome's new AI promises to streamline home buying, but its debut raises questions about market disruption, ethics, and the future of real estate.

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