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- FDA approves first drug for type 1 narcolepsy and greenlights mRNA flu vaccine; AstraZeneca and BMS deny merger talksThe U.S. Food and Drug Administration has granted approval for the first therapy specifically targeting type 1 narcolepsy, marking a milestone for patients with this rare sleep disorder. In a sepa…
- FDA says MDUFA VI will prioritize review consistency and domestic focus over faster timelinesFDA officials explained that the next Medical Device User Fee Amendments, known as MDUFA VI, will aim to improve consistency in the review process. The agency said the new framework will emphasize…