11 July 2025
11 July 2025
By disclosing the CRLs, the FDA provides an insight into common pitfalls that sponsors must rectify to gain approval.
IGI Therapeutics will be entitled to $1.225bn on reaching development milestones and targets.
The US dominates overall market sales, yet GlobalData research indicates that China is shaping up to be a formidable presence in the cell therapy space.
The designation is supported by positive results from the IMPACT-I study.
Despite the threat of a 200% tariff, most pharma stocks remained stable.
The transaction will enhance Merck's cardio-pulmonary pipeline and portfolio with the addition of Ohtuvayre, an FDA-approved COPD treatment.
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