Regulatory and manufacturing strains surfaced this week: the FDA placed Tenaya Therapeutics’ heart‑disease gene therapy trial on hold while the company standardizes immunosuppression practices across sites. Separately, Catalent announced additional layoffs at its Baltimore gene‑therapy facility tied to reduced demand from a major commercial customer. The Tenaya hold highlights heightened FDA attention on clinical‑site consistency for gene therapy regimens. Catalent’s workforce reductions underscore that downstream manufacturing demand remains volatile even as investment in genetic medicines grows. Biotechs must now navigate tighter regulatory expectations and supply‑chain realities when planning trials and commercial launches.