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about the author
Lia DeGroot
ldegroot@endpointsnews.com
author articles
NIH officials used personal emails, tweaked words to skirt FOIA searches during pandemic, lawmakers find
12 months ago
Pharma
FDA+
Public Citizen sues FDA over citizen petition on SSRI sexual side effects labeling
Last year
FDA+
Law
European Commission finalizes joint clinical assessment rules for member countries
Last year
Pharma
Law
House committee presses FDA center directors on domestic manufacturing, LDTs
Last year
Pharma
FDA+
FDA's Marks, Woodcock talk regulatory flexibility for new rare disease drugs
Last year
Cell/Gene Tx
FDA+
Sen. Wyden questions Pfizer over tax rate as part of ongoing investigation
Last year
Pharma
FDA+
FDA withdraws Helsinn’s accelerated approval for cancer drug after company’s request
Last year
Pharma
FDA+
Study identifies groups of people who mistrust the FDA
Last year
Pharma
FDA+
House panel advances bills targeting rare disease, priority review vouchers
Last year
Pharma
FDA+
FDA offers more clarity on safety testing for cell therapies
Last year
Cell/Gene Tx
FDA+
WHO members miss deadline for pandemic accord draft, will continue talks
Last year
Pharma
FDA+
New Biosecure draft features 2032 grandfather clause, five-year grace period for added companies
Last year
China
Pharma
Ahead of likely approval, ICER finds Geron’s imetelstat is not cost-effective at $250,000 annually
Last year
Pharma
FDA+
House panel marks up bill to require PBMs to use a flat fee in Medicare
Last year
Pharma
FDA+
White House unveils long-awaited policy on overseeing research of concern
Last year
Pharma
FDA+
House Oversight chair presses FDA on China amid growing tensions
Last year
China
FDA+
Sen. Cassidy calls on Biden to do better at sharing H5N1 bird flu information
Last year
Pharma
FDA+
House to mark up bill targeting Chinese biotech and genomics companies
Last year
China
Pharma
ICER pushes back on FDA's potential conversion of Sarepta's gene therapy to full approval
Last year
Pharma
Cell/Gene Tx
Senator alleges GSK is shirking its commitment to lower inhaler costs
Last year
Pharma
FDA+
FDA asks for public input on advisory committee reforms
Last year
Pharma
FDA+
FDA finalizes long-awaited rule to bring lab tests under its purview
Last year
Pharma
FDA+
FDA greenlights label update to Gilead's Biktarvy to include more data in pregnant people
Last year
Pharma
FDA+
Sanders presses pharma leaders to change stance on Pandemic Accord proposals
Last year
Pharma
FDA+
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