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Merck Scraps Covid Therapy on Data Request

[ Price : $8.95]

Merck says it is stopping development of MK-7110 for treating hospitalized patients with Covid-19 due to additional FDA data reque...

Priority Review for BioMarins Vosoritide

[ Price : $8.95]

FDA grants priority review to a BioMarin NDA for vosoritide to treat achondroplasia.

FDA Remote Inspections Could Continue After Pandemic: Attorneys

[ Price : $8.95]

Two Sheppard Mullins attorneys analyze a recent FDA guidance on remote facility evaluations during the pandemic and suggest the ag...

Panbela Therapeutics Clinical Hold Lifted

[ Price : $8.95]

FDA lifts a partial clinical hold against a Panbela Therapeutics Phase 1 first-line study of SBP-101 when used in combination with...

FDA, HHS Withdraw Device Exemptions Notice

[ Price : $8.95]

Federal Register notice: FDA and HHS withdraw a 1/15 notice that proposed exemptions for 83 Class 2 devices and one unclassified d...

Qorvo EUA for Covid Antigen Test

[ Price : $8.95]

FDA grants Qorvo an emergency use authorization for the Qorvo Omnia SARS-CoV-2 Antigen Test.

Genesis Herb Operators to Plead Guilty to FDA Charges

[ Price : $8.95]

The Justice Department says two men who operated Genesis Herb, a dietary supplement manufacturer in Ohio, intend to plead guilty t...

Info Collection: New Dietary Ingredient Notifications

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Federal Register notice: FDA sends to OMB an information collection extension entitled Premarket Notification for a New Dietary In...

Info Collection on Radiopharmaceuticals

[ Price : $8.95]

Federal Register notice: FDA submits to OMB an information collection extension entitled Regulations for In Vivo Radiopharmaceutic...

FDA Debarment Order Against Pharmacist Reinhard

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Federal Register notice: FDA issues an order permanently debarring Mark Reinhard from providing services in any capacity to a pers...