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Experts suggest the FDA’s Advanced Manufacturing Technologies designation could be a lifeline for improving production processes for approved cell and gene therapies.

Bristol Myers Squibb delivered better than expected fourth quarter earnings, but Eliquis missed expectations while Cobenfy continues to struggle with uptake.

While the FDA continues to put out guidance documents and approve drugs, some companies are already reporting delays in dealings with the agency, while insiders warn of falling morale and a negative perception from the rest of the biopharma world.

Out-licensing drugs to multinational corporations is a natural step for Chinese biotechs, but the recent rise in deals is only scratching at the surface of partnership-ready biotechs in the region.

Analysts called the approval a much-needed win for Novo Nordisk, but warned that the company could struggle to grow sales once rival drugs come to market.

The deal marks an end for CAR T company Cargo Therapeutics, which has been slashing its workforce and cutting programs since the January decision to halt its lead candidate for a certain type of aggressive large B cell lymphoma.

The 2025 Bioprocessing Summit revealed knowledge gaps and changing mindsets. As some companies look towards the future, others struggle with the present and past.

Facing declining valuations and funding challenges, public biotechs like bluebird bio are going private to restructure, reduce regulatory burdens and refocus on long-term growth.

BioSpace remembers COVID-19 five years after the pandemic was declared, Novo Nordisk’s CagriSema again misses expectations as the company joins a lawsuit filed by drug compounders against the FDA, Viking secures ample supply of its investigational obesity medication, J&J strikes out in depression, and Makary and Bhattacharya near confirmation.