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FDA Promotion Crackdown Enters New Phase: Attorneys

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Attorneys from Arnall Golden Gregory examine and offer advice on FDAs intensified scrutiny of drug advertising, advising companies...

Senate Report Raises Questions About Oversight of Mifepristone Providers

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A new report from Senate HELP chair Bill Cassidy (R-LA) targets FDA for allowing the abortion drug mifepristones Risk Evaluation a...

Boebert Bill to Ease Botanical Drug Development

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Rep. Lauren Boebert introduces legislation to remove some barriers to the development of botanical drugs.

Support, Suggestions for Expedited IND Pilot

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Five stakeholders support an FDA proposal for an expedited IND pilot program and suggest ways to improve it.

PDUFA 8 Commitment Letter Analyzed

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Akin Gump attorneys highlight major issues in the PDUFA 8 commitment letter that is now open for public comment.

QMSR Finding Single Risk Thread: Report

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MasterControl issues its 2026 life sciences regulatory readiness playbook demonstrating the significant ways in which the FDA Qual...

Court Upholds FDA Shortage Resolution Decision on Lillys Tirzepatide

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The U.S. Court of Appeals for the Fifth Circuit upholds FDAs decision to remove tirzepatide from the agencys drug shortage list, a...

Courts Rejecting Loper Arguments in Product Liability: Attorney

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Reed Smith attorney James Beck says courts so far have rejected all arguments citing the Supreme Courts Loper Bright decision as a...

Celcuity Files sNDA for Revtorpyk Expanded Use

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Celcuity files a supplemental NDA for Revtorpyk (gedatolisib) for treating certain patients with hormone receptor positive, human ...

FDA OKs RevMeds Promising Pancreatic Cancer Drug

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FDA approves Revolution Medicines Rasonque (daraxonrasib), a RAS inhibitor for the most common form of pancreatic cancer.