The approval marks Korea's first homegrown oncology drug cleared by the FDA and is being watched as a test of investor sentiment toward Korean biotech.

The therapy is only the second US-approved option for fibrodysplasia ossificans progressiva, a disease affecting roughly 300 people in the US that turns muscle

A positive panel vote moves the blood-based multi-cancer screening test closer to US clearance, a milestone for the MCED field.

The head-to-head result strengthens Novo's position in the obesity market as competition with Eli Lilly intensifies.

The regulatory setback, alongside an ongoing probe, weighs on ABL Bio even as its broader pipeline offers rebound prospects.

The pullback delays one of the most closely watched DXd antibody-drug conjugates in a hard-to-treat tumor type.

The clearance expands the companies' renal cell carcinoma franchise into a new advanced-disease setting.

The three-month extension pushes back a potential approval in a rare epilepsy indication.

The EU clearance gives Sanofi a novel mechanism in a form of MS that has lacked dedicated treatment options.

The rolling review begins a regulatory path for an optogenetic therapy aimed at restoring vision in advanced retinal disease.

The label expansion extends the JAK inhibitor to younger patients with severe hair loss.

The advance could improve delivery and precision for in vivo gene editing, where compact enzymes are prized.

The long-term CAR-T data support earlier use of the therapy in multiple myeloma.

The insider trading case involves confidential agency approval information used for stock trades.

The durable result supports single-dose gene editing as a long-acting approach to cardiovascular risk.

Positive late-stage results for Moderna's personalized cancer vaccine reinforce the mRNA oncology strategy.

The regulatory correspondence has prompted shareholder scrutiny of the hematology-focused biotech.

The exemption eases cost pressures on Korean-made biologics exported to the US market.