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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.

HHS to Appoint 2 New FDA Deputy Commissioners: CNBC

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CNBC reports that HHS plans to appoint two new FDA deputy commissioners in hopes of exerting more influence over the agency.

Boston Scientific ENROUTE System Recall is Class 1

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FDA says the Boston Scientific recall of its ENROUTE Transcarotid Neuroprotection System is Class 1.

Do More to Capture Nonprescription Drug Use Info: Meeting

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Participants in a 4/23 FDA meeting on increasing access to nonprescription drugs see a need to improve the electronic health recor...

Osfamide Shortage Seen

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An oncology physician association says its members are reporting a shortage of the chemotherapy agent ifosfamide for which no dire...