Qualitative Concept
FDA Approves Keytruda for First-Line Treatment of Malignant Pleural Mesothelioma
Keytruda, FDA approval, malignant pleural mesothelioma, MPM, first-line treatment, chemotherapy, pembrolizumab
FDA Enhances Transparency in Drug Review Process with Revised Document Structure
FDA, drug review process, transparency, document structure, regulatory oversight
Novartis’ Kisqali Secures Broad FDA Approval for Adjuvant Treatment of Early Breast Cancer
Kisqali, Novartis, FDA Approval, Early Breast Cancer, Adjuvant Treatment, HR+/HER2- Breast Cancer, CDK4/6 Inhibitors
FDA Issues Draft Guidance on Integrating Clinical Trials into Routine Clinical Practice and Enhancing Diversity in Clinical Studies
FDA, clinical trials, diversity, routine clinical practice, decentralized clinical trials, underrepresented populations, FDORA
FDA Updates Guidance to Combat Online Misinformation About Medical Products
FDA, online misinformation, medical products, guidance, regulatory clarity, public health
FDA Approves Lilly’s Ebglyss for Moderate-to-Severe Atopic Dermatitis
Ebglyss, atopic dermatitis, eczema, FDA approval, Eli Lilly, lebrikizumab, biologic treatment
AstraZeneca’s Imfinzi Demonstrates Significant Survival Benefit in Muscle-Invasive Bladder Cancer, Raises Questions on FDA Approval for Perioperative Design
AstraZeneca, Imfinzi, durvalumab, muscle-invasive bladder cancer, MIBC, perioperative trial design, FDA approval, survival benefit
Incyte’s PD-1 Drug Zynyz: A Strategic Pipeline Component Despite Recent Trial Success
Incyte, Zynyz, PD-1 inhibitor, anal cancer, pipeline strategy, clinical trials, FDA approval
ESMO24: AstraZeneca’s Imfinzi and Imjudo Combination Doubles 5-Year Overall Survival Rate in Advanced Liver Cancer
AstraZeneca, Imfinzi (durvalumab), Imjudo (tremelimumab), Advanced Liver Cancer, Unresectable Hepatocellular Carcinoma (HCC), 5-Year Overall Survival Rate, ESMO24
FDA Approves Ebglyss (Lebrikizumab-lbkz) for Moderate-to-Severe Atopic Dermatitis in Adults and Children 12 Years and Older
Ebglyss, Lebrikizumab-lbkz, FDA Approval, Moderate-to-Severe Atopic Dermatitis, Eczema Treatment