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Roche Data on Crovalimab Met Primary Endpoints

[ Price : $8.95]

A Roche Phase 3 study called COMMODORE 2 that was evaluating the efficacy and safety of crovalimab in certain people with paroxysm...

FDA Offers Advisory Committee Hearing on Intarcia Dispute

[ Price : $8.95]

FDA proposes an advisory committee-led hearing to address a CDER 2021 decision not to approve an NDA submitted by Intarcia Therape...

MicroVention Costa Rica Has QS Issues

[ Price : $8.95]

FDA warns Alajuela, Costa Rica-based MicroVention Costa Rica about Quality System regulation violations in the manufacture of micr...

QS, Other Violations at Getsch+Hiller Medizintechnik

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FDA warns Nendingen, Germany-based Getsch+Hiller Medizintechnik about Quality System violations in its production of adulterated a...

Info Collection on FDA Formal Hearings

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Federal Register notice: FDA seeks comments on an information collection extension entitled FDA Administrative Practices and Proce...

MD Sentenced in Avanir Kickbacks

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Former physician Deepak Raheja (Hudson, Ohio) gets 30 months in prison after pleading guilty to pharmaceutical kickback conspiracy...

Abbott Expanded Indication for Ablation Catheter

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FDA approves an Abbott expanded indication for its FlexAbility Ablation Catheter, Sensor Enabled, a flexible tip catheter intended...

Tezspire Approved as Pre-filled Pen for Asthma

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FDA approves AstraZeneca and Amgens asthma drug Tezspire (tezepelumab) in a self-administration pre-filled, single-use pen for pat...

Meeting on Developing Digital Health Technologies

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Federal Register notice: FDA announces a 3/28-29 public workshop entitled Understanding Priorities for the Development of Digital ...

Workshop on Generic Drug Science Initiatives

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Federal Register notice: FDA announces a 5/11 public workshop entitled FY 2023 Generic Drug Science and Research Initiatives Works...