News & Analysis

Curated news and analysis on clinical trials, drug approvals, and medical research.

Clinical Trials Market Projected to Reach $99.25 Billion by 2033

The clinical trials industry is expected to grow from $61.93 billion in 2025 to $99.25 billion by 2033 at a 6.07% CAGR, driven by demand for innovative therapies and chronic disease prevalence. Clinical trials management systems are projected to reach $9.0 billion by 2035.

FDA Accepts Roche's Giredestrant Filing for ESR1-Mutated Breast Cancer

The FDA has accepted Roche's new drug application for oral SERD giredestrant in ESR1-mutated, ER-positive advanced breast cancer, with a decision expected by December 18, 2026. The filing is restricted to the ESR1-mutant population despite phase 3 trial benefits in broader patients.

FDA Accepts Roche NDA for Giredestrant in ESR1-Mutated Breast Cancer

The FDA has accepted Roche's New Drug Application for giredestrant plus everolimus to treat ESR1-mutated, ER-positive advanced breast cancer, with a decision expected by December 18, 2026. The filing is based on phase III data showing significant reductions in disease progression risk.

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