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Human Drugs

FDA Warns Makers of Supplements with Cesium Chloride

FDA warns five dietary supplement manufacturers that they are producing products containing cesium chloride without meeting agency requirements for us...

FDA General

FDA Represents Science in Action: Hahn

FDA commissioner Stephen Hahn promises that all Covid-19 decisions in the future will be based on science and data, and not politics, just as they hav...

Human Drugs

Biohaven sNDA for Migraine Prevention Drug

FDA accepts for review a Biohaven Pharmaceutical Holding supplemental NDA for Nurtec ODT (rimegepant) for preventing migraines.

Human Drugs

Clinical Hold on Voyager Therapeutics Gene Therapy

FDA places a clinical hold on a Voyager Therapeutics planned clinical trial for VY-HTT01 for treating Huntingtons disease.

Medical Devices

Require Better De Novo Evidence: Researchers

Researchers say FDA could ensure better evidence in medical device de novo clearances by requiring that devices meet prespecified effectiveness endpoi...

Medical Devices

FDA Clears ImmersiveTouch Surgical Planner

FDA clears an ImmersiveTouch 510(k) for its ImmersiveView Surgical Plan digital surgery platform.

Human Drugs

Dont Expect Much from New Drug Import Programs: Analysis

Hogan Lovells attorneys say that new FDA and CMS drug importation provisions are unlikely to lead to any increase in drugs imported from Canada or low...

Human Drugs

NIH Pauses Lilly Covid Antibody Trial

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

FDA General

Latest FDA Warning Letters

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

Medical Devices

miR Scientific Gain Breakthrough for Prostate Assay

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