Biologics License Application (bla) - Vaccines

Relevant Publications

DLL3-guided therapies in small-cell lung cancer: from antibody-drug conjugate to precision immunotherapy and radioimmunotherapy.

Issue Release: 2024

Redefining Pulmonary Arterial Hypertension Treatment: Sotatercept\'s FDA Priority Review.

Issue Release: 2024

Rare oncology therapeutics: review of clinical pharmacology package of drug approvals (2019-2023) by US FDA, best practices and recommendations.

Issue Release: 2023

Bringing function to the forefront of cell therapy: how do we demonstrate potency?

Issue Release: 2023

The Advisory Committee on Immunization Practices\' Recommendation for Use of Moderna COVID-19 Vaccine in Adults Aged ≥18 Years and Considerations for Extended Intervals for Administration of Primary Series Doses of mRNA COVID-19 Vaccines - United States, February 2022.

Issue Release: 2022

Inebilizumab-cdon: USFDA Approved for the Treatment of NMOSD (Neuromyelitis Optica Spectrum Disorder).

Issue Release: 2022

Navigating the Regulatory Pathways and Requirements for Tissue-Engineered Products in the Treatment of Burns in the United States.

Issue Release: 2021

The Advisory Committee on Immunization Practices\' Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine in Children Aged 5-11 Years - United States, November 2021.

Issue Release: 2021

Disitamab Vedotin: First Approval.

Issue Release: 2021

The Advisory Committee on Immunization Practices\' Interim Recommendations for Additional Primary and Booster Doses of COVID-19 Vaccines - United States, 2021.

Issue Release: 2021

Bayesian hierarchical model for safety signal detection in multiple clinical trials.

Issue Release: 2020

Acceleration of rare disease therapeutic development: a case study of AGIL-AADC.

Issue Release: 2019

Scale-down model qualification of ambr® 250 high-throughput mini-bioreactor system for two commercial-scale mAb processes.

Issue Release: 2019

Advancing Biologics Development Programs with Legacy Cell Lines: Advantages and Limitations of Genetic Testing for Addressing Clonality Concerns Prior to Availability of Late Stage Process and Product Consistency Data.

Issue Release: 2019

The Current Status of Drug Discovery and Development as Originated in United States Academia: The Influence of Industrial and Academic Collaboration on Drug Discovery and Development.

Issue Release: 2018

A GUIDE TO FOLLOW-ON BIOLOGICS AND BIOSIMILARS WITH A FOCUS ON INSULIN.

Issue Release: 2018

Patterns of use and impact of standardised MedDRA query analyses on the safety evaluation and review of new drug and biologics license applications.

Issue Release: 2017

Summary of the US FDA approval of belatacept.

Issue Release: 2012

US biosimilar pathway unlikely to be used: developers will opt for a traditional BLA filing.

Issue Release: 2011

Utilization of electronic resources in the NDA/BLA regulatory review of bioanalytical data: perspectives from US FDA reviewers.

Issue Release: 2011

How is Vaccine Stability Ensured?

What Role Do Immune Markers Play?

Where Can I Get the HPV Vaccine?

How Effective is the MMR Vaccine?

How does a Cytokine Storm Relate to Vaccines?

How is Efficacy Data Used in Regulatory Approval?

What are the Challenges to Elimination?

What are Vaccines?

Which Vaccines are Recommended for Chronic Conditions?

What is the Future of Genetic Engineering in Vaccinology?

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