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- FDA approves prostate cancer and Crohn’s disease therapies as judge rejects effort to block Lilly weight‑loss adsThe U.S. Food and Drug Administration announced approvals for new treatments targeting prostate cancer and Crohn’s disease. The decisions expand therapeutic options for patients with these conditio…
- FDA officials share guidance on de novo device classifications and upcoming MDUFA VI changes at MedTech ConferenceAt the MedTech Conference in Boston, FDA officials and industry experts discussed de novo classification requests. They offered practical tips for companies seeking de novo designation, stressing…