The list includes several groundbreaking therapies that are expected to change the treatment landscape for several diseases and conditions.

Sleep apnea “occurs when a person’s upper airway becomes blocked, causing pauses in breathing during sleep,” per the FDA. “Today’s approval marks the first drug treatment option for ...

Incyte and Syndax Pharmaceutical said the Food and Drug Administration approved their graft disease treatment Niktimvo antibody in nine milligram and 22 milligram vial sizes.

In that single-arm study, the rate of primary adverse events within 7 days of ablation was 2.9%, with the most common ...

As 2025 begins, we would like to reflect on last year’s regulatory developments in the biologics and biosimilars space. Here are ...

The drug is sold under the brand name SYFOVRE. The FDA approved systemic pegcetacoplan in May 2021 for the treatment of adults with PNH. The drug is sold under the brand name Empaveli. The FDA ...

Ionis Pharmaceuticals CEO Brett Monia stated: "Today's FDA approval of TRYNGOLZA heralds the arrival of the first-ever FCS treatment in the US – a transformational moment for patients and their ...

New partnerships aim to expand Teva’s biosimilar portfolio and enhance access to high-cost biologics across key markets.

The temporary pause follows reports of four cases of neurovascular events in the US external evaluation study.