The Food and Drug Administration’s traditional approval process involves a series of rigorous clinical trials that can take as long as a decade to set up, oversee, and evaluate. The agency has become more flexible with this standard, especially in cases where medicines may help people facing fatal or debilitating diseases. Now, however, some of the ways the FDA speeds up the drug approval process are coming under increasing scrutiny. Our latest report unpacks the differences between the different ways the FDA approves drugs, like accelerated approvals, fast-track designations, and emergency use authorizations  — and how those pathways could change in the future. Learn more about this report.

Gone are the days where a type 1 diabetes diagnosis meant a lifetime of finger pricking and injections. Today, almost half of the 4 million Americans living with type 1 diabetes use devices called continuous glucose monitors, or CGMs, to monitor their glucose and regulate their insulin levels in real-time. As the market for CGMs grows — to $5 billion in 2021, by some estimates — so too does the optimism that they will also be able to help manage the flood of unmanaged type 2 diabetes. In our latest report, written by STAT’s Katie Palmer, we’ve gathered our best intelligence on the burgeoning industry of CGM, and where it’s likely to head next. Learn more about this report.

It may come as a shock, but the world of psychedelic drugs has gone legit. With long-stigmatized drugs like Eskatamine, MDMA and psilocybin advancing rapidly through clinical trials for treatments of a range of mental health conditions, entrepreneurs and investors alike are flooding the market. Our latest report, written by STAT’s Olivia Goldhill, explores the opportunities for growth in this nascent industry — and the regulations and patenting barriers that could stymie profit. Learn more about this report.

Which venture capital firms get the best returns? Our latest STAT Report is an update of our most popular report to date, this time with 2020 data. In it, STAT’s Kate Sheridan answers provides a definitively ranked list of more than a dozen of the biggest names in biotech investment: including Third Rock Ventures, OrbiMed, ARCH Venture Partners, and even Flagship Pioneering. Learn more about this report.

As the world stares down the developing threat of antibiotic-resistant superbugs, the antibiotic pipeline — and the critical gap in the research and development of novel drugs — is garnering renewed attention. Our latest STAT Report, written by STAT pharmaceutical powerhouse Ed Silverman, explores the factors that have led to the rise of antimicrobial resistance in recent years. It also considers the social, political and economic factors that have led small biotechs and behemoth drug makers alike to shorten their antibiotic pipelines, and the solutions for addressing that. Learn more about this report.

In the late 1950s a radical idea was born: What if a patients’ gastrointestinal inflammation could be cured by implanting a healthier gut? The result, now known as a fecal microbiota transplant, is the foundation, 60 years later, of the microbiome industry. This report examines the science behind this nascent industry, fleshing out what we know about the ecology of the human microbiome and the various interventions scientists are studying to help keep or make it healthy. It also looks at the vast array of conditions that microbiome companies are hoping to treat, and the challenges that these biotechs face in research, manufacturing, regulation and ultimately bringing these treatments to the clinic. Learn more about this report.

Synthetic biology is not a new field. But it’s moving at warp speed thanks to advances in machine learning, artificial intelligence, and automation. Investment in companies working in this field are rapidly expanding, with the industry receiving $7.8 billion in private and public financing in 2020 — nearly 2 1/2 times the amount poured into the industry in 2019. This report will help you develop a deeper understanding of synthetic biology and key players. In addition to explaining the tools at the heart of synthetic biology, the report offers a closer look at 10 companies taking the field by storm, including bit.bio, Synlogic, Twist Biosciences, eGenesis, and Strateos. Learn more about this report.

If you’ll pardon the pun, nanotechnology is big. The science of manipulating molecules and materials under 100 nanometers in size is spurring advances in drug development, diagnosis, and treatment. In our latest STAT Report, we look at the different kinds of nanomaterials being developed for medical applications, how they work, and the treatments in which they are being used. We also examine the key companies involved in bringing nano-products to market; the challenges they’re facing in demonstrating safety and efficacy; and the ways they’re trying to overcome them. Learn more about this report.

As health care grows increasingly virtual, a shift accelerated by the Covid-19 pandemic, tech giants and startups alike are racing to stake out their territory, rapidly developing tools that can monitor health — or even diagnose disease — from a distance. But regulators are struggling to keep pace with technological advances, and remote patient monitoring still faces significant obstacles to reach its market potential. This STAT Report explores the hope and the hype of this emerging industry, and examines the leaders of some of the sector’s most promising and prominent companies. Learn more about this report.

Which venture capital firms get the best returns? In this 50-page STAT Report, Kate Sheridan answers just this with a definitively ranked list of more than a dozen of the biggest names in biotech investment: including Third Rock Ventures, OrbiMed, ARCH Venture Partners, and even Flagship Pioneering. Learn more about this report.

Interpreting clinical trial results is not for the faint of heart. Companies spin, short-sellers hawk, and everyone else is left swimming through the muck. But there is an art to reading scientific results — and you can learn it. In this report, STAT’s Sharon Begley and Adam Feuerstein provide basic tools to help you read clinical trial results with an appropriately skeptical (or at least critical) eye. They also examine specific examples of spin, noting the sections of papers reporting the results of clinical trials where they appear — and why that matters. Learn more about this report.

In China, biotechnology long lagged behind the industry in the West. Now, thanks to billions of dollars in state and private investment — and dramatic regulatory changes — what took a half century of iteration in the U.S. has happened over the course of about 20 years in China. In this STAT Report, we feature the 20 most important executives leading this revolution. Learn more about this report.

Gene therapies were once dismissed as too dangerous to introduce to the treatment landscape. But today they are making a comeback with hundreds of products in the pipeline and under trial. In this STAT Report, we dive into the science, and business, of viral vector technologies. We spoke with executives from 18 companies to identify the pipeline of therapies that are nearing the clinic, the engineering and production challenges that may stifle progress, and how key players are looking to overcome those challenges. Our aim: to make the problems, stakes, and possibilities clear to everyone — whether you’re an executive, investor, or policymaker actively working in the space, or patients and families interested in learning more. Learn more about this report.

Biosimilars — nearly identical versions of biologic drugs — have been heralded as a salve for the skyrocketing costs of prescription medications used to treat a wide variety of diseases. But so far they have been a disappointment. In this STAT Report, we dive into the regulations and manufacturing limitations that have acted as barriers to entry, as well as the companies that have managed to succeed in the space. Learn more about this report.

This 140-page report profiles over 50 venture capital firms that invest in biotechnology — from firms that specialize in biotech (or in health care in general), to generalists who are pumping money into the broader technology sector, with biotech as part of the mix. This is an ideal report for startups looking to raise venture capital, and to navigate the field of opportunity from coast to coast. Learn more about this report.