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- J&J gets FDA clearance for general surgery robot; study finds 90% of approved drugs meet post-marketing commitmentsJ&J received FDA authorization for a general‑surgery robot, a notable regulatory step for the company. The FDA is also being urged to ban direct‑to‑consumer drug advertisements, highlighting ongoi…
- EMA seeks input on draft revisions to biosimilar efficacy guidanceThe European Medicines Agency has issued a draft concept paper and is asking stakeholders for feedback on proposed revisions to its guideline for biosimilar efficacy studies. The changes are inten…