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Priority Voucher Awarded to Neurocrine Biosciences

[ Price : $8.95]

Federal Register notice: FDA announces it has issued a priority review voucher to Neurocrine Biosciences because its 12/13 NDA app...

Fresenius Recalls Ivenix Infusion Pumps

[ Price : $8.95]

Fresenius Kabi recalls its Ivenix Infusion System due to potential pneumatic valve failures that may cause the pump to stop an act...

J&J Pauses Varipulse Rollout

[ Price : $8.95]

Johnson & Johnson says it is pausing the limited U.S. rollout of its new Varipulse ablation technology while it investigates the r...

Breakthrough Status for Heart Failure Device

[ Price : $8.95]

FDA grants Alleviant Medical a breakthrough designation for its no-implant atrial shunt technology for treating heart failure with...

Create Labeling-only NDA: Report

[ Price : $8.95]

Three RebootRx executives call on FDA to create a labeling-only 505(b)(2) NDA pathway to allow non-manufacturers to seek approval ...

Annes Daye Pulls CBD Tampons in U.S.

[ Price : $8.95]

Annes Daye says it is pulling its CBD-coated tampons from the U.S. market following receipt of an FDA Warning Letter.

Draft Guide on Optical Imaging Drugs

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Federal Register notice: FDA makes available a draft guidance entitled Developing Drugs for Optical Imaging.

Guide on Developing Obesity Drugs

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Obesity and Overweight: Developing Drugs and Biological Pro...

6 Human Cell, Tissue Donor Eligibility Guides

[ Price : $8.95]

FDA publishes one draft general and five specific immediately effective guidances to help establishments understand regulations go...

Priority Review for Verastem Ovarian Cancer NDA

[ Price : $8.95]

FDA grants a priority review for a Verastem Oncology NDA for avutometinib, an oral RAF/MEK clamp for use in combination with defac...