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FDA Sees New Ocaliva Liver Injuries

[ Price : $8.95]

FDA says it has identified serious liver injuries in patients without cirrhosis of the liver being treated for primary biliary cho...

Keros Halts Some Dosing in Cibotercept Trial

[ Price : $8.95]

Keros Therapeutics stops some dosing in a Phase 2 clinical trial of cibotercept (KER-012) in combination with background therapy i...

FDA Hasnt Inspected Factory with Recalls: ProPublica

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A detailed ProPublica investigative report says FDA failed to inspect a Glenmark Pharmaceuticals facility in India that had multip...

Trump Unclear on Abortion Pills in Interview

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In a Time interview, president-elect Donald Trump said it has always been his commitment to preserve access to abortion pills, but...

Generics Seek Legislation to End Drug Sameness Delays

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The Association for Accessible Medicines urges Congress to pass pending legislation to allow FDA to disclose sameness information ...

FDA Launches RWE Evidence Innovation Center

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FDA launches the CDER Center for Real-World Evidence Innovation with four areas of initial focus.

U.S. Approves More New Drugs than EU, Japan: Analysis

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An IQVIA analysis of novel active substance approvals from 2014 to 2022 in the U.S., EU, and Japan shows the U.S. approves more ne...

J&J Impella Heart Pumps Get Expanded Indications

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FDA approves a Johnson & Johnson MedTech PMA supplement for expanded indications for the Impella 5.5 with SmartAssist and Impella ...

Pfizer Reports Favorable Ibrance Breast Cancer Data

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Pfizer says data from the Phase 3 PATINA trial demonstrated that adding Ibrance (palbociclib) to current standard-of-care first-li...

Fresenius Kabi Pump Early Alert

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CDRH issues an early alert on a Fresenius Kabi high-risk Ivenix large-volume pump issue, the Centers first alert under a new commu...