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Darzalex OKd for Multiple Myeloma Combo Therapy

[ Price : $8.95]

FDA approves Janssen Biotechs Darzalex (daratumumab) in combination with Amgens Kyprolis (carfilzomib) and dexamethasone for relap...

Policy on Bioavailability/Bioequivalence Retention Samples

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance on bioavailability and bioequivalence samples retention.

FDA Issues Stay on Certain Electrical Stimulation Device Use

[ Price : $8.95]

Federal Register notice: FDA issues a stay of effectiveness provisions for electrical stimulation devices for use on certain self-...

Is NAC a Drug or a Dietary Supplement?

[ Price : $8.95]

Some dietary supplement manufacturers are concerned that FDA may be cracking down on products that include N-acetylcysteine, which...

Predictive Biotech Selling Unapproved Covid Cures: FDA

[ Price : $8.95]

FDA warns Predictive Biotech that it is marketing an unapproved and misbranded umbilical cord-derived product as a Covid-19 treatm...

Executive Summary on Talc Public Meeting Clarified

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Federal Register notice: FDA clarifies that an executive summary of a public meeting on Testing Methods for Asbestos in Talc and C...

Blood Plasma Emergency Use Authorization Stalls

[ Price : $8.95]

FDA holds up an emergency use authorization for using blood plasma therapy for treating Covid-19 patients until more data is prese...

Gilead Filgotinib Complete Response Letter

[ Price : $8.95]

FDA issues a complete response letter to Gilead for its filgotinib to treat rheumatoid arthritis, seeking information from two stu...

FDA Rebuffs BioMarin BLA for Hemophilia Gene Therapy

[ Price : $8.95]

FDA issues a complete response letter for a Phase 3 trial of BioMarins gene therapy for severe hemophilia A.

Covid-19 Inspection Questions and Answers

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FDA issues an immediately effective guidance to answer questions about some regulatory and policy issues during the Covid-19 publi...