Regulatory Approval

Dupixent's landmark FDA approval offers a new, surgery-sparing option for a debilitating sinus disease, but questions of access and cost remain.

New research reveals the limits of automation in global HR, showing why human judgment and strategic advice are becoming essential for navigating a complex world.

Despite missing its primary goal, Cadrenal Therapeutics' drug CAD-1005 drastically cut deadly blood clots, setting up a crucial FDA meeting for a new path forward.

Amidst industry-wide regulatory challenges, Meridian secures critical IVDR certification for its Alethia assays, ensuring continued market access in Europe.

Vico's novel RNA therapy moves to a patient-friendly regimen in Europe and secures FDA clearance for US trials, offering new hope for rare neurological diseases.

Larimar Therapeutics' nomlabofusp receives Breakthrough Therapy Designation, paving an accelerated path for a potential disease-modifying treatment.

Cullinan Therapeutics heads to key investor conferences, ready to showcase its T-cell engager platform for both cancer and challenging autoimmune diseases.

With its Moda-flx system cleared by the FDA, Diality hires M&A expert Peter Donato to navigate the path to commercialization in the $92B dialysis market.

New Phase 1b data for oral drug pociredir reveals a robust boost in fetal hemoglobin, as Fulcrum Therapeutics secures a financial runway into 2029.

A new 'technology-only' law firm has been approved in the UK. Can its deterministic AI make legal help more affordable and consistent for everyone?

Beam Therapeutics is set to announce its 2025 financial results and a new liver-targeted therapy, a key moment for its base editing platform and investors.

As stablecoin rules tighten, a new partnership between Circle and CyberScope signals a major shift towards institutional-grade security in Web3.

A lucrative deal for a rare disease voucher positions Fortress Biotech for profitability, highlighting a successful strategy and a breakthrough for Menkes patients.

As Lyell presents at three major investor conferences, the biotech's pipeline, financial health, and future in cancer therapy are under scrutiny.

A Malaysian biotech's new study shows its NK cell therapy is safe, using a novel, low-cost method that could make advanced cancer treatment affordable worldwide.

With a novel skin drug launched, Pelthos Therapeutics heads to a key conference. Can its focused strategy convince Wall Street of its blockbuster potential?

With its newly approved VIZZ eye drop, LENZ Therapeutics is wooing investors, aiming to capture a slice of the massive, underserved presbyopia market.

A Swiss firm begins human trials for a non-glucose dialysis solution, aiming to end a 30-year reliance on problematic treatments for kidney patients.

With stockholder approval, Abbott's acquisition of Exact Sciences is set to reshape the cancer diagnostics landscape and accelerate early detection.

Teva and Medincell’s once-monthly olanzapine injection shows promise in trials, potentially freeing patients from burdensome post-injection observation.