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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...

DTC Ad Enforcement to Increase Under Trump: Panel

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Lawyers on a Food & Drug Law Institute enforcement panel warn that the incoming Trump administration is likely to target and seek ...

FDA Revokes EUAs for B.Braun Covid Devices

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Federal Register notice: FDA announces the revocation of B. Braun Medical emergency use authorizations for three Covid-related dev...

Regulating AI in Healthcare: Paragon White Paper

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A Paragon Health Institute white paper suggests an approach to regulating healthcare artificial intelligence that it says builds o...

NeuroSense Gets FDA Agreement for ALS Study

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Based on FDA feedback, NeuroSense Therapeutics says it will begin a Phase 3 study of PrimeC (ciprofloxacin and celecoxib) for trea...

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...

Stakeholders Comment on Patient Preference Guide

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Four stakeholders suggest changes to a CDRH/CBER draft guidance on incorporating patient preference information over the total pro...

Furosemide Injection sNDA Faces Submission Delay

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scPharmaceuticals says a planned supplemental NDA submission of an autoinjector as an alternative to the current on-body infusor u...