source
- 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…
- Sarepta delays Elevidys study readout while Emergent cuts 90 jobsSarepta Therapeutics told investors that the readout for its non‑ambulatory Elevidys trial will not be available by the end of the year as previously expected. The company indicated the delay durin…