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Human Drugs

Court Upholds FDA Shortage Resolution Decision on Lillys Tirzepatide

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

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Human Drugs

Courts Rejecting Loper Arguments in Product Liability: Attorney

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

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Human Drugs

Celcuity Files sNDA for Revtorpyk Expanded Use

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

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Human Drugs

FDA OKs RevMeds Promising Pancreatic Cancer Drug

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

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Human Drugs

Osfamide Shortage Seen

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

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Medical Devices

FDA Issues Alert on Abiomed Impella Controllers

CDRH issues an early alert to notify the public about an Abiomed action recommending that all Automated Impella Controllers be removed from where they...

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Human Drugs

Petition Seeks Carbetocin OK for Postpartum Hemorrhage

Two physicians affiliated with Stanford Universitys medical school urge FDA to approve carbetocin for preventing postpartum hemorrhage.

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FDA General

HHS to Appoint 2 New FDA Deputy Commissioners: CNBC

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

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Medical Devices

Boston Scientific ENROUTE System Recall is Class 1

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

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Human Drugs

Do More to Capture Nonprescription Drug Use Info: Meeting

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