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After greenlighting 56 novel therapeutics in 2025, four notable applications continue to await the agency’s action after being delayed from the fourth quarter last year.

The prevalence of serious inflammatory safety issues such as cytokine release syndrome and immune effector cell–associated neurotoxicity syndrome limits the reach of these transformative cancer therapies.

The purchase is expected to expand Haemonetics’ impact in fast-growing markets for structural heart and endovascular procedures.

CMR Surgical received the approval for abdominal surgery for its Versius platform in patients under age 18 in Europe, while SS Innovations will incorporate five new instruments into its SSi Mantra system.

Insmed’s freshly approved lung condition drug soared past sales expectations for 2025, netting $144.6 million in its first full quarter of sales.

David Marin will become president and chief executive of the Pharmaceutical Care Management Association effective Jan. 30.

Rumors of a Revolution buyout come as the industry gears up for one of its biggest trade conferences, where observers expect many such deals to be announced.

Aside from the layoffs, InflaRx will deprioritize Gohibic, a COVID-19 antibody that was granted emergency use authorization in 2023. The therapy failed a late-stage trial in a rare skin disease last year.

Pharmas will need to provide their latest stance on the Most Favored Nation drug pricing plans, while biotech finally gets a break after a few tough years.

Rampart Bioscience was working on a platform to deliver gene therapies without the need for viral vectors.