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- FDA issues complete response letter rejecting ITM Isotope's radiopharma therapy over manufacturing concernsFDA sent a complete response letter rejecting the NDA for ITM Isotope's investigational radiopharmaceutical, citing manufacturing and third-party facility issues. The agency said there were no con…
- Hims & Hers says it can quickly launch six wellness peptides if FDA lifts banHims & Hers used its second‑quarter earnings call to explain that it is preparing to offer six consumer wellness peptides that are currently prohibited for compounding pharmacies. The company says…