Conditional Marketing Authorization - Cancer Science

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Relevant Publications

Access to Innovative Medicines: Regulation Change and Factors Associated with Drug Approval Lag in Malaysia.

Issue Release: 2024

Balancing ethical norms and duties for the introduction of new medicines through conditional marketing authorization: a research agenda.

Issue Release: 2024

Cost-Effectiveness Analysis of Etranacogene Dezaparvovec Versus Extended Half-Life Prophylaxis for Moderate-to-Severe Haemophilia B in Germany.

Issue Release: 2024

Case report: Envafolimab causes local skin necrosis.

Issue Release: 2024

Post-marketing surveillance framework of cell and gene therapy products in the European Union, the United States, Japan, South Korea and China: a comparative study.

Issue Release: 2024

Biomarker-driven therapy in endometrial cancer.

Issue Release: 2023

Factors associated with early relapse of infantile haemangioma in children treated for at least six months with oral propranolol: A case-control study using the 2014-2021 French Ouest DataHub.

Issue Release: 2023

Clinical Treatment Guidelines for Tafasitamab Plus Lenalidomide in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma.

Issue Release: 2023

Clinical development time is shorter for new anticancer drugs approved via accelerated approval in the US or via conditional approval in the EU.

Issue Release: 2023

European Conditional Marketing Authorization in a Rapidly Evolving Treatment Landscape: A Comprehensive Study of Anticancer Medicinal Products in 2006-2020.

Issue Release: 2023

Self-Reported Allergic Adverse Events Following Inactivated SARS-CoV-2 Vaccine (TURKOVAC™) among General and High-Risk Population.

Issue Release: 2023

Regulatory Issues: PMDA - Review of Sakigake Designation Products: Oncolytic Virus Therapy with Delytact Injection (Teserpaturev) for Malignant Glioma.

Issue Release: 2023

Comparison of the Latin America Regulation Landscape and International Reference Health Authorities to Hasten Drug Registration and Clinical Research Applications.

Issue Release: 2023

Neurological side effects and drug interactions of antiviral compounds against SARS-CoV-2.

Issue Release: 2023

The characteristics and regulations of adaptive designs from 2008 to 2020: An overview of European Medicines Agency approvals.

Issue Release: 2023

Analysis of participant-reported adverse events following the first dose of inactivated SARS-Cov-2 vaccine (TURKOVAC™) through telephone survey in Türkiye.

Issue Release: 2023

Glofitamab: First Approval.

Issue Release: 2023

Nirmatrelvir and ritonavir combination: an antiviral therapy for COVID-19.

Issue Release: 2023

Comparison between European Medicines Agency and US Food and Drug Administration in Granting Accelerated Marketing Authorizations for Covid-19 Medicines and their Utilized Regulations.

Issue Release: 2023

The reimbursement decision speed for oncology new drugs in China and its determinant factors.

Issue Release: 2023

Which Contaminants in Water are Linked to Cancer?

How to Use References to Support Hypotheses?

How Long is a Treatment Cycle?

What Role Do Technology and Data Play?

What are the Challenges in Evidence-Based Cancer Care?

What Types of Data Should be Shared?

What is Freedom of Speech in Healthcare?

How Do They Improve Drug Delivery?

Who Can Join These Organizations?

How Do Human Errors Affect Imaging?

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