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.

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.

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.

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.

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.

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?