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As leadership changes create more instability at the FDA, here’s what one former agency official thinks it will take to keep speedier drug approvals on track.

Involving up to 12 antibody drugs, the alliance is the latest broad partnership between Chinese biotech and a multinational pharmaceutical company.

The findings supporting bepirovirsen were deemed a “historic moment” by physicians and validate a drug that has “clear blockbuster potential,” according to one analyst.