Regulatory

UAE to Lead Affordable CAR-T Therapy with New Biomanufacturing Hub
Biotech & Bioprocessing UAE to Lead Affordable CAR-T Therapy with New Biomanufacturing Hub

In a groundbreaking initiative, Burjeel Holdings is joining forces with Caring Cross to establish advanced biomanufacturing facilities dedicated to chimeric antigen receptor (CAR)-T cell therapies in the United Arab Emirates (UAE). This collaboration aims to revolutionize the production and

Is Columvi the Game-Changer for Refractory DLBCL Treatment?
Management & Regulatory Is Columvi the Game-Changer for Refractory DLBCL Treatment?

Roche's Columvi, a bispecific antibody known as glofitamab, has been approved by the European Commission (EC) for use in combination with gemcitabine and oxaliplatin (GemOx) to treat relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in adults who are not candidates for autologous

Navigating Medtech Challenges: Regulatory, Reshoring, and Tech Gaps
Management & Regulatory Navigating Medtech Challenges: Regulatory, Reshoring, and Tech Gaps

The medical and life sciences manufacturing sector is experiencing rapid transformations, bringing forth a plethora of challenges and opportunities for industry professionals. Ascential's "2025 State of Medical & Life Sciences Manufacturing" report delves into key areas such as

Will Mehmet Oz Revolutionize Telehealth with New CMS Policies?
Management & Regulatory Will Mehmet Oz Revolutionize Telehealth with New CMS Policies?

The rapid advancements in telehealth have been met with a mixture of enthusiasm and concern, especially as regulatory frameworks struggle to keep pace with technological innovations. At the center of this challenge is Mehmet Oz, the newly appointed Administrator of the Centers for Medicare

Novartis' Vanrafia Approved by FDA for Rare Kidney Disease Treatment
Management & Regulatory Novartis' Vanrafia Approved by FDA for Rare Kidney Disease Treatment

Ivan Kairatov is a recognized authority in the biopharma sector, with an extensive background in technological advancements and R&D. In this interview, Ivan shares his insights on the new FDA-approved treatment for IgA nephropathy (IgAN), shedding light on its significance in treating this rare

HHS Layoffs and Reorganization Spark Opposition and Legal Action
Management & Regulatory HHS Layoffs and Reorganization Spark Opposition and Legal Action

The U.S. Department of Health and Human Services (HHS) is experiencing a turbulent phase marked by extensive layoffs and a major reorganization under Secretary Robert F. Kennedy Jr. These moves have ignited substantial controversy and legal battles, drawing sharp reactions from various stakeholders

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