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NIH Pauses Lilly Covid Antibody Trial

[ Price : $8.95]

The NIH puts a safety hold on the Abbott ACTIV-3 trial of a Covid-19 antibody therapy.

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that include Haloderm and Oneness Labs.

miR Scientific Gain Breakthrough for Prostate Assay

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FDA grants miR Scientific a Breakthrough Device Designation for its miR Sentinel PCC4 Assay for prostate cancer analysis.

Haloderm Marketing Unapproved New Drugs: FDA

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FDA warns Haloderm that it is marketing unapproved new homeopathic drugs to remove moles.

Gap Between Drug Approval and Clinical Needs: Study

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A study reported in the BMJ says FDA and EMA should explore better ways to inform patients and doctors about the therapeutic ratin...

Janssen Covid Vaccine Trial Paused Over Unexplained Illness

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Johnson & Johnson says an unexplained illness in a study participant has temporarily paused dosing in its Janssen Covid-19 vaccine...

Optimal Health Selling Unapproved Cellular Products: FDA

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FDA says Optimal Health Stem Cell and Wellness Institute is marketing cellular products to treat several diseases and conditions w...

Pfizers Ibrance Misses Endpoint in Breast Cancer Trial

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Pfizer and the German Breast Group say a Phase 3 study involving Ibrance (palbociclib) did not meet the primary endpoint of improv...

CartiHeal Gets Breakthrough Status for Agili-C Implant

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FDA grants CartiHeal a breakthrough device designation for the Agili-C implant and its use in treating cartilage lesions in arthri...

Joint Panel Backs Alkermes Antipsychotic

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Two FDA advisory committees vote to support approval of an Alkermes NDA for ALKS 3831 (olanzapine/samidorphan), an oral atypical a...