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FDA publishes more than 200 archived CRLs for transparency

By disclosing the CRLs, the FDA provides an insight into common pitfalls that sponsors must rectify to gain approval.

Latest news

IGI and AbbVie sign licence deal for cancer and autoimmune therapy

IGI Therapeutics will be entitled to $1.225bn on reaching development milestones and targets.

CTO East Coast 2025: Global oncology cell therapy market to hit $25bn by 2031

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.

FDA gives TSND-201 breakthrough therapy designation for PTSD

The designation is supported by positive results from the IMPACT-I study.

Trump’s 200% tariff threat could send shockwaves through pharma supply chains

Despite the threat of a 200% tariff, most pharma stocks remained stable.

Merck agrees to acquire Verona Pharma for $10bn

The transaction will enhance Merck's cardio-pulmonary pipeline and portfolio with the addition of Ohtuvayre, an FDA-approved COPD treatment.