Citeline, a Norstella company

News. Context. Impact.

In-depth journalism and analysis of the pharma, biotech, medtech, and consumer health industries.

FDLI: Clinical Labs Face Uncertainty After Texas Court’s LDT Ruling

A Texas court's decision against US FDA regulation of lab-developed tests (LDTs) has introduced new uncertainties for clinical labs. Industry stakeholders are now worried about potential future regulations while also managing existing compliance requirements. Recent conference discussions underscored the complexities of FDA oversight.

New Vaccine Framework Avoided Worst-Case Scenario, Analysts Say

The new US FDA vaccine guidelines introduced on 20 May might cause financial woes for Moderna, but overall vaccine makers should not be as impacted as feared.

UroGen’s Bladder Cancer Drug Draws Split Decision From US FDA Panel

The Oncologic Drugs Advisory Committee voted 5-4 that the overall benefit-risk of UGN-102 is not favorable in patients with recurrent low grade, intermediate-risk, non-muscle invasive bladder cancer and also divided on whether randomized trials should be required for future development programs.

US FDA Will Help States Apply To Import Cheaper Drugs From Canada

The FDA is not currently signaling that stringent rules for the process will be relaxed, but the agency's change in approach is notable.

Edwards Lifesciences Holds 2025 EPS Outlook Despite Tariff Headwind

The brunt of the tariff exposure stems from Singapore and Costa Rica, which together account for an estimated 70% to 80% of the tariff-related cost burden. Less than 10% of the exposure is tied to China.

Cipla Leadership’s Early Take On Trump’s Pricing EO And Pipeline Progress

Cipla's CEO underlines that US generic prices are already “very significantly comparable” with the rest of the world and expects President Donald Trump's executive order on drug pricing to primarily impact branded pharmaceuticals. The company also shared updates on its US pipeline.

Lupin CEO On Trump’s Most Favored Nation Policy, Tariffs, Firm’s Five-Year Plan

Lupin CEO Vinita Gupta speaks on Trump’s most favored nation policy, the Inflation Reduction Act’s “pill penalty” and other developments in the US, a major market for the company. The company also outlines a five-year plan focused on complex generics and technology platforms.

‘We Can’t Keep Going On Like This’ – Biosimilars Forum’s Reed Calls For Urgent Changes In US

As the US biosimilars market moves into its second decade, urgent changes are needed at the FDA if biosimilars are to meet their full potential, according to Biosimilars Forum chief executive Julie Reed.

Legal, Process Problems May Plague New US FDA COVID-19 Vaccine Policy

The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.

US FDA COVID-19 Booster Strategy May Not Be As Controversial As It Seems

US FDA Commissioner Martin Makary’s call for placebo-controlled trials to confirm the efficacy of COVID-19 boosters is drawing a lot of criticism, but former Commissioner Robert Califf also supported the idea.

US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

Califf In Conversation: ‘Decimated’ US FDA Teams Endanger Innovation

Pink Sheet sister publication In Vivo spoke to the former FDA commissioner about the recent layoffs and their impact on vaccine and other product development.

Scrip is an invaluable source of information and insight about key developments in the biopharmaceutical industry. It has produced some of the most detailed reporting about emerging therapeutics in our field (the liver disease nonalcoholic steatohepatitis), with crisp perspective on scientific, business and regulatory dynamics.

Chris Frates, VP of Corporate Communications and Patient Advocacy
Madrigal Pharmaceuticals

I've been reading Generics Bulletin for over a decade now and it is really of great help to understand the latest news related to generics and biosimilars, including Licensing and M&A deals as well as new Authorities regulations.

Alex Falgas, Global SVP - BD Portfolio & Strategy
Corporate Europe & MENA, Accord Healthcare

Medtech Insight is my go-to source for everything medical devices in the EU and UK. Medtech Insight not only provides timely updates but also analysis that provides insight beyond mere description

Johan Ordish, Head of Digital Health and Innovation Policy
Roche Diagnostics

engaging articles

Engaging Articles

Engaging Articles

Quick to read yet rich in insight, our articles cover a diverse range of topics, delivering sharp, comprehensive analysis in every piece.

contextualized news

Contextualized News

Contextualized News

Go beyond the headlines with our in-depth news coverage, offering background and analysis to ensure you're fully informed on global events.

in-depth reports

Future Trends Analysis

Future Trends Analysis

Discover emerging trends and innovative ideas with our forward-thinking thought-leadership providing actionable insights and visionary perspectives.

thought-provoking podcasts

Thought-Provoking Podcasts

Thought-Provoking Podcasts

Listen to expert-led discussions and analysis through our engaging podcasts, designed to inform and inspire—whenever and wherever you are.

timely features

Timely Features

Timely Features

Stay up-to-date with our regularly updated features, delivering the latest trends, insights, and developments as they unfold.

exclusive conference coverage

Exclusive Conference Coverage

Exclusive Conference Coverage

Get insider access to major industry events with our detailed conference coverage, bringing you the latest insights from top leaders and innovators.

7,000+In-Depth Articles

Expert insights delivered throughout the year

500+Executive Interviews

Exclusive perspectives from industry leaders

2,000+In-Depth Analyses

Deep dives into critical issues and trends

500+Interactive Media

Engaging visual, audio and dynamic content

Our Expertise at a Glance

Discover how our dedicated team delivers unparalleled insights through rigorous research and expert analysis.


Citeline Expertise At A Glance
Citeline News and Insights Journalists
60+ Respected Journalists

Our team of over 60 trusted journalists operates across the US, Canada, UK, and Asia, delivering multilingual content.

Human Intelligence Filter
Human Intelligence Filter

Local teams meticulously review industry news, filtering out 50-90% of the noise to highlight key events.

Citeline Conference Coverage
In-Person Meeting Coverage

Our journalists attend key events both in person and virtually, ensuring comprehensive coverage.

Citeline Research
Thorough Research

We analyze regulatory and policy changes, check internal data, consult in-house analysts, review sell-side reports, and interview multiple sources.

Expert Interviews
Expert Interviews

We engage with company executives, clinical/medical KOLs, regulatory agencies, patient advocacy groups, payer organizations, lawyers, and other experts.

Citeline Premium News Coverage
Premium News with Context

Our premium news includes in-depth analysis, insightful interviews, and comprehensive data.

In-Depth Analysis Powered by Citeline Data

Our global journalists leverage Citeline’s advanced analytics platforms to perform comprehensive data analysis and uncover valuable insights.

In Depth Industry Analysis
  • Industry-Leading Market Analysis Tools: Comprehensive commercial, clinical, and regulatory insights.
  • Real-Time Data Trends: Up-to-the-minute data for the latest industry developments.
  • AI-Driven Solutions: Innovative technology accelerating drug development and delivery to patients.
  • Custom Insights with Ask-the-Analyst: Tailored answers and analysis to address your specific questions.

These powerful tools deliver a wealth of information—from detailed industry reports to real-time data trends—enabling reporting that sets us apart from the rest.

Citeline app
Download App

Expert Analysis Across The Decades

With a rich history and commitment to excellence our seasoned journalists have consistently provided crucial industry insights, reflecting years of dedicated expertise.

Expert Analysis Across The Decades
2003
Generics Bulletin

News and Expert Analysis on Generics and Biosimilars

1981
In Vivo

Strategic Analysis for Medtech and Pharma Leaders

1980
HBW Insight

News and Expert Analysis on the Healthcare Industry

1975
Medtech Insight

News and Expert Analysis for Medtech Decision Makers

1972
Scrip

Pharma News and Expert Analysis for Commercial Decision Makers

1939
Pink Sheet

News and Expert Analysis on Pharma Policy and Regulation

1906
US FDA

Beginnings of
today's FDA


Karen Coleman

Karen Coleman

Executive Director,
News and Insights

Ian Haydock

Ian Haydock

Editor-in-Chief,
APAC

Matt Hobbs

Nielsen Hobbs

Editor-in-Chief,
Pink Sheet

Eleanor Malone

Eleanor Malone

Editor-in-Chief,
Commercial Insights

Andrea Charles

Andrea Charles

Vice President
Custom Content