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First Covid Test Authorized Outside of an EUA

[ Price : $8.95]

FDA grants Quidel a de novo marketing authorization for its Sofia 2 SARS Antigen+ FIA, Sofia SARS Antigen FIA Control Swab Set, wh...

Determine NMN is a Dietary Supplement: Petition

[ Price : $8.95]

Two natural product stakeholders petition FDA to determine that nicotinamide mononucleotide can legally be a dietary supplement.

Lithium Citrate Not Withdrawn Due to Safety/Efficacy

[ Price : $8.95]

Federal Register notice: FDA determines that a Hikma Pharmaceuticals NDA for lithium citrate oral solution was not withdrawn due t...

FDA Extends Review Date for BioMarins Roctavian

[ Price : $8.95]

FDA extends to 6/30 the PDUFA action date for BioMarins Roctavian gene therapy for adults with severe hemophilia A.

FDA Highlights Proactive and Innovative Opioid Research

[ Price : $8.95]

An FDA Clinical Pharmacology Corner post highlights four recent agency articles on aspects of its efforts to tackle the opioid epi...

Thomas Advanced Medical Illegally Selling HCT/Ps: FDA

[ Price : $8.95]

FDA warns Thomas Advanced Medical about illegally marketing human cell and tissue products.

FDA Withdraws Fosun ANDA for Pemoline

[ Price : $8.95]

Federal Register notice: FDA withdraws approval of a Fosun Pharma ANDA for pemoline tablets after the company requested it be with...

Abbott Alinity I Concussion Blood Test Cleared

[ Price : $8.95]

FDA clears an Abbott 510(k) for its Alinity i TBI blood test for detecting traumatic brain injuries.

FDA Plans Immune Globulin Adverse Reactions Workshop

[ Price : $8.95]

FDA announces a 3/30 workshop entitled Immune Globulin (IG) Hypersensitivity Reactions: Root Causes and Mitigation that is intende...

Update Accelerated Approval Labels with Required Info: Study

[ Price : $8.95]

Researchers call on drug companies to ensure that labels for drugs with accelerated approval indications contain approval pathway ...