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Marketing

Lower Added Benefit Associated with Higher DTC Spend

Johns Hopkins University researchers say spending on direct-to-consumer ads in 2020 was associated with drugs rated with lower added clinical benefit ...

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Human Drugs

Court Throws Out PhRMA Lawsuit on Drug Importation

The DC District Court dismisses for lack of standing a Pharmaceutical Research and Manufacturers of America-led lawsuit that sought to block HHS and F...

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Human Drugs

Roche Data on Crovalimab Met Primary Endpoints

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

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Human Drugs

FDA Offers Advisory Committee Hearing on Intarcia Dispute

FDA proposes an advisory committee-led hearing to address a CDER 2021 decision not to approve an NDA submitted by Intarcia Therapeutics for ITCA 650 (...

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Medical Devices

MicroVention Costa Rica Has QS Issues

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

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Medical Devices

QS, Other Violations at Getsch+Hiller Medizintechnik

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

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Federal Register

Info Collection on FDA Formal Hearings

Federal Register notice: FDA seeks comments on an information collection extension entitled FDA Administrative Practices and Procedures; Formal Hearin...

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Medical Devices

FDA Urges Reporting of Home Covid Test Results

FDA revises its online guide on when and how often people should use an over-the-counter at-home Covid-19 test to encourage users to self-report their...

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Biologics

Takeda sBLA for Takhzyro Expanded Indication

FDA approves a Takeda supplemental BLA for an expanded use of Takhzyro (lanadelumab-flyo) prophylaxis to prevent attacks of hereditary angioedema in ...

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Federal Register

Determinations on 31 Drugs Available for ANDAs

Federal Register notice: FDA determines that 31 drug products were not withdrawn from sale due to safety or effectiveness reasons.