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Haloderm Marketing Unapproved New Drugs: FDA

[ Price : $8.95]

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...

Edge Pharma Gets 17-page Form 483

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An FDA inspection of Colchester, VT-based Edge Pharma ends in a 17-page Form FDA 483 that cites numerous GMP deficiencies.

Meeting on Ranking Animal Antimicrobial Drugs

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Federal Register notice: FDA announces 11/16 virtual public meeting entitled Potential Approach for Ranking of Antimicrobial Drugs...

Avenue Gets Complete Response on Pain Drug

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FDA issues Avenue Therapeutics a complete response letter due to safety concerns on its NDA for intravenous tramadol, indicated fo...