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Medical Devices

NeuroOne Medical Brain Electrodes Get Clearance

FDA clears a NeuroOne Medical Technologies 510(k) to market its Evo sEEG Electrode technology for temporary (less than 30 days) use for the recording,...

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Human Drugs

Imjudo/Imfinzi Approved for Liver Cancer

FDA approves AstraZenecas Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) for treating adult patients with unresectable liver cancer.

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Federal Register

Guide on ANDA In Vitro Permeation Studies

Federal Register notice: FDA makes available a draft guidance entitled In Vitro Permeation Test Studies for Topical Products Submitted in ANDAs.

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Federal Register

ANDA Physicochemical/Structural Characterization Guide

Federal Register notice: FDA makes available a draft guidance entitled Physicochemical and Structural (Q3) Characterization of Topical Drug Products i...

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Human Drugs

Tremfya 80% Response Rate in Ulcerative Colitis: Janssen

Janssen Pharmaceutical says new data show that patients given Tremfya (guselkumab) saw a clinical response rate of about 80% in trial subjects with mo...

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Human Drugs

FDA Explains Why Zepzelca Will Not be Withdrawn

Responding to a petition seeking the removal of approval for Jazz Pharmaceuticals lung cancer drug Zepzelca, FDA explains why it doesnt agree with the...

Human Drugs

FDA Approves Biologic for Some Myelomas

FDA gives accelerated approval to Janssens teclistamab-cqyv for some adults with relapsed or refractory multiple myeloma.

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Human Drugs

FDA Airs Daprodustat Safety Concerns

FDA medical reviewers tell members of the Cardiovascular and Renal Drugs Advisory Committee there are safety concerns with GlaxoSmithKlines anemia dru...

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Federal Register

ANDA In Vitro Release Test Studies Guide

Federal Register notice: FDA makes available a draft guidance entitled In Vitro Release Test Studies for Topical Products Submitted in ANDAs.

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Federal Register

Guidances on ANDA Bioequivalence for Topicals

Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances for developing topical drug products.