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Healthcare Staff Can Misinterpret Sterilization Indicators: FDA

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FDA says there is a potential for healthcare facility staff to misinterpret indicator colors used to signify whether a medical dev...

TG Theraputics Positive Results in Leukemia Stopped Trial

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TG Therapeutics announces positive topline results from the UNITY-CLL Phase 3 trial evaluating the combination of umbralisib plus ...

FDA OKs Grifols Procelix Panther System

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FDA approves Grifols Procelix Panther System for use with several U.S. licensed Procelix assays.

Objectionable Conditions at University of Kentucky Lab

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FDA warns the University of Kentucky laboratory about deviations from good laboratory practices for nonclinical studies.

Whistleblower Report Details FDA Hydroxychloroquine Role

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A whistleblower report by ousted Biomedical Advanced Research and Development Authority director Rick Bright details the roles of ...

Cytomegalovirus Treatment Guidance

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FDA issues a guidance to aid development and clinical trial designs for drugs to treat cytomegalovirus in specified post-transplan...

FDA Nixes Devices Referencing Drugs New Uses

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Federal Register notice: FDA announces that it is abandoning a 9/2017-published approach that would have enabled device sponsors t...

Farxiga Gets Expanded Approval in Heart Failure

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FDA approves AstraZenecas Farxiga (dapagliflozin) oral tablets for adults with heart failure with reduced ejection fraction to red...

Eased FDA Enforcement Not Likely Permanent: Attorneys

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Two Mintz attorneys say FDAs relaxed enforcement on medical devices during the Covid-19 public health emergency is not likely to c...

Cabaletta Wins Fast Track for CAAR T-cell

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FDA grants Cabaletta Bio fast track status for DSG3-CAART (Desmoglein 3 Chimeric Auto-Antibody Receptor T cells) for treating muco...