Tagged with FDA

USA Paul Kim, a leading FDA attorney and policy expert formerly at both the FDA and the US Congress, discusses the current shifts within the American life sciences and regulatory landscape. Kim examines the prevailing sentiment of the industry amidst a period of significant structural upheaval and regulatory whiplash. He offers…

USA The FDA’s Sarah Yim discusses the evolving regulatory landscape for biosimilars in the US, the shift toward analytical-heavy reviews over large clinical studies, the legislative push to simplify interchangeability, and the agency’s commitment to increasing market competition and patient access through streamlined development pathways. My goal, and the FDA goal…

USA Patients and carers with lived experience of a disease have valuable insights to share with physicians and drug developers alike. This is especially true of rare diseases, defined in the US as those that affect fewer than 200,000 people nationwide and which collectively impact over 30 million Americans. For these…

USA As rare disease science accelerates, regulators face growing pressure to adapt without compromising rigour. In this interview, Amy Comstock Rick explains how the FDA Rare Disease Innovation Hub is strengthening cross-centre coordination, evolving evidence expectations for ultra-rare conditions, and creating new spaces for dialogue between regulators, developers, and patients. The…

Global 2025 was a year of volatility for pharma and healthcare. In particular, the speed with which the administration of Donald Trump makes (and often then changes) consequential policy decisions has left industry stakeholders in the US and globally scrambling to fall in line. There are already clear winners and losers…

Taiwan Taiwan is, in many ways, a healthcare model for Asia. The island has had universal health coverage for over 30 years and Taiwan’s life expectancy today is almost 81 years, putting it behind only Japan, South Korea, and Singapore in its region. However, by the early 2020s, this rapidly ageing…

Taiwan Dr Chih-Kang Chiang, Director-General of the TFDA, shares how Taiwan is redefining regulation through science, transparency, and international collaboration. Combining his backgrounds in medicine, toxicology, and law, he leads efforts to strengthen patient safety, accelerate innovation in AI and regenerative medicine, and reinforce supply resilience. This conversation offers insight into…

USA Richard Pazdur, MD, Director of the Oncology Centre of Excellence (OCE) at the US Food and Drug Administration (FDA), leads the agency’s efforts to streamline and modernize the regulation of cancer therapies. Since its creation in 2017, the OCE has become a hub for innovation, fostering collaboration across FDA centres,…

USA The latest stories from healthcare and the life sciences in the US. Vinay Prasad is reinstated as head of the FDA’s CBER following a brief resignation; HHS fires Gray Delany amid fallout from abrupt mRNA contract cuts; the federal Task Force on Safer Childhood Vaccines is revived after three decades…

USA The latest stories from healthcare and the life sciences in the US. The FDA names Stanford’s George Tidmarsh as the new head of CDER; AstraZeneca commits USD 50 billion to new US manufacturing and R&D projects; Moderna cancels its planned mRNA facility in Japan; Sarepta refuses to halt Elevidys shipments…

Global 2023 may have been a breakthrough year for cell and gene therapies with the FDA approving a record of seven novel treatments, but 2024 did not fall behind in the number of greenlit therapies. With seven new approvals and three expanded indications, the cell and gene therapies authorized by the…

Saudi Arabia Saudi Arabia’s pharmaceutical sector continues its impressive growth leadership within the region. With a 9.1 percent market growth in 2024 and a projected USD 11.6 billion in sales, the Kingdom now commands nearly a third of the entire MENA pharma market. But this story goes far beyond impressive numbers. Through…