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Lilly Plans NDA for Oral Weight-Loss Drug

[ Price : $8.95]

Eli Lilly says it will file an NDA by the end of the year for its investigational obesity treatment orforglipron, based on just-an...

Valneva Chikungunya OK to Use Again: FDA

[ Price : $8.95]

FDA lifts an earlier recommended pause on the use of Valnevas Ixchiq vaccine for chikungunya virus.

FDA Steps to Boost U.S. Drug Production

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FDA says it is starting the FDA PreCheck program to help drug companies develop manufacturing facilities in the U.S.

ICH Extractables, Leachables Guide

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FDA publishes a draft International Council on Harmonization guideline for extractables and leachables to solicit public comment.

Julie Tierney Joins Leavitt Partners

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Former FDAer Julie Tierney is now a principal in Leavitt Partners Washington office.

J&J Complete Response Letter on Darzalex Faspro

[ Price : $8.95]

FDA issues Johnson & Johnson a complete response letter for its supplemental BLA for Darzalex Faspro (daratumumab and hyaluronidas...

Instylla PMA Approved for Hypervascular Tumors

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FDA approves an Instylla PMA for its Embrace Hydrogel Embolic System, a liquid embolic device for treating hypervascular tumors in...

QS, MDR Issues at Taiwans Visgeneer

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FDA warns Taiwans Visgeneer, Inc., about Quality System and Medical Device Reporting violations in its manufacturing of blood gluc...

Medical Device PFAS Appear Safe: FDA

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FDA issues an online post describing the safety to patients of the type of PFAS used in medical devices.

BMS Files Breyanzi Marginal Zone Lymphoma sBLA

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FDA accepts for priority review a Bristol Myers Squibb supplemental BLA for Breyanzi (lisocabtagene maraleucel; liso-cel) as a pot...