Regulatory Approval

After resolving a key manufacturing issue, Unicycive has resubmitted its kidney drug NDA, offering new hope for dialysis patients with a lower pill burden.

Bluejay Diagnostics can now make 9 million sepsis tests. This manufacturing win is huge, but the real race for FDA approval has only just begun.

Diamyd Medical's pivotal Phase 3 trial gets a nine-month acceleration, raising hopes for a new precision therapy that preserves insulin production.

Mirum raises over a quarter-billion dollars to acquire Bluejay Therapeutics, targeting a high-potential liver disease drug and signaling major growth.

Alvotech and Teva's settlement with Regeneron for an Eylea biosimilar paves the way for a 2026 launch, promising increased competition and lower costs.

A new settlement positions a cost-effective alternative to the blockbuster eye drug Eylea for a 2026 U.S. launch, signaling intense market disruption.

A new oral drug, cadisegliatin, enters a major clinical trial in the UAE, aiming to help Type 2 diabetes patients struggling with insulin therapy.

Johnson & Johnson's TRUFILL n-BCA gains FDA approval for chronic subdural hematoma, offering a minimally invasive option to curb high rates of recurrence.

A new FDA approval for an EGFR-mutated lung cancer therapy cuts treatment from hours to minutes, offering new hope and convenience for thousands of patients.

With FDA approval for a pivotal study, Pulse Biosciences' novel nanosecond ablation technology aims to make atrial fibrillation treatment safer and more precise.

Celltrion's SteQeyma autoinjector gets a CHMP nod, enhancing patient care and intensifying competition in Europe's crowded biosimilar market.

Incyte's Minjuvi, a first-of-its-kind immunotherapy, gains EC approval for follicular lymphoma, offering patients a powerful new chemo-free option.

A new once-monthly, self-injected cholesterol drug gets FDA nod, offering more convenience and setting the stage for a major market push in China.

Ayrmid and RoslinCT forge a key manufacturing pact for a new SAA therapy, revealing the critical infrastructure needed for resilient biotech returns.

A breakthrough clinical trial and a savvy financial move could net Fractyl Health $18M to advance its novel obesity treatment beyond the GLP-1 boom.

A decade-long wait ends as the FDA approves a new 1st-line therapy for HER2+ breast cancer. See how ENHERTU reshapes patient outcomes and market dynamics.

IO Biotech’s cancer vaccine posts impressive 5-year survival data, but a narrow miss in its pivotal trial creates an uncertain path in a competitive market.

Verastem Oncology taps industry heavyweights for its leadership, signaling a bold new strategy to accelerate its cancer pipeline and grow its market share.

A Minneapolis firm is testing a graft that helps the body rebuild its own arteries. This could end a painful, risky part of traditional heart bypass surgery.

As Spruce Biosciences preps its rare disease drug for FDA review, the addition of a commercial veteran signals a high-stakes shift from R&D to market.