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Human Drugs

Partial Hold Modified in Myotonic Dystrophy Study

FDA modifies a partial clinical hold on an Avidity Biosciences study involving AOC 1001, allowing Avidity to double the number of participants in the ...

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Human Drugs

ICU Medical Recalls Pumps Over Battery Defect

ICU Medical recalls the replacement batteries in its in Plum A+ & Plum A+3 Infusion Systems due to a manufacturing defect by a battery supplier.

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Federal Register

Susceptibility Test Interpretive Criteria Updated

Federal Register notice: FDA posts its annual compilation of notices of updates to the agencys antimicrobial test interpretive criteria Web page.

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Federal Register

Device Panel to Tackle Health Equity

Federal Register notice: CDRH plans a 9/6 Patient Engagement Advisory Committee meeting that will discuss and make recommendations on advancing health...

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Human Drugs

Reviewers Question Intercepts Liver Drug

FDA asks the Gastrointestinal Drugs Advisory Committee whether it recommends approval of Intercepts obeticholic acid to treat pre-cirrhotic liver fibr...

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Bill to Use Industry Penalties for Cancer Research

A bipartisan group of members of Congress introduce legislation to redirect penalties paid by drug, cosmetic, supplement, and medical device companies...

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FDA General

Califf Hopeful on Alzheimers, Obesity Drug Data

FDA commissioner Robert Califf tells the Food and Law Institutes annual meeting that the U.S. could be on the verge of seeing major impacts from new d...

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Human Drugs

Drug Company Patent Violations Cost $40 Billion: Study

The American Economic Liberties Project and the Initiative for Medicine, Access, and Knowledge recommend policy changes to curb drug company patent ab...

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Human Drugs

Reject Apotex Generic Fintepla ANDA: UCB

UCB petitions FDA not to approve an Apotex ANDA for generic Fintepla unless its labeling includes specified information from the reference-listed drug...

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Human Drugs

Takeda Priority BLA for Clotting Disorder

FDA accepts for priority review a Takeda BLA for TAK-755, an enzyme replacement therapy for treating congenital thrombotic thrombocytopenic purpura.