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Covid-19 Blood Purification System Gets EUA

[ Price : $8.95]

FDA issues an emergency use authorization to Terumo BCT and Marker Therapeutics for their Spectra Optia Apheresis System and Depur...

Earthly Wellness Warned on Covid-19 Unapproved Products

[ Price : $8.95]

FDA sends a Warning Letter to Earthly Wellness over unapproved and misbranded products related to Covid-19.

Novartis Updating Beovu Labeling Over Safety Signal

[ Price : $8.95]

Novartis says it is seeking revised prescribing information with Beovu (brolucizumab) after confirming a safety signal involving r...

Temporary Policy on PPE Used in Drug Compounding

[ Price : $8.95]

FDA issues a guidance entitled Temporary Policy Regarding Non-Standard PPE Practices for Sterile Compounding by Pharmacy Compounde...

Steris Gets EUA for N-95 Respirator Decontamination

[ Price : $8.95]

FDA issues a second emergency use authorization for decontaminating compatible N95 or N95-equivalent respirators for reuse by heal...

AstraZenecas Koselugo OKd for Pediatric Neurofibromatosis

[ Price : $8.95]

FDA approves an AstraZeneca NDA for Koselugo (selumetinib) for treating of pediatric patients with neurofibromatosis type 1, a ner...

Vapotherm Gets Breakthrough Status for Oxygen Assist

[ Price : $8.95]

FDA grants Vapotherm a breakthrough device designation for its Oxygen Assist Module for use in the companys Precision Flow system....

Guide on Human Research Protections During Covid-19

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FDA directs industry to a new guidance from HHS Office for Human Research Protections entitled OHRP Guidance on Covid-19.

DeGette Wants FDA Drug Hoarding Action

[ Price : $8.95]

Rep. Donna DeGette calls on FDA to take several steps to ensure that patients who need hydroxychloroquine and chloroquine for appr...

Medtronic Gets Ventilator EUA

[ Price : $8.95]

Medtronic describes several actions to increase its manufacturing of ventilators to help patients hospitalized with Covid-19.