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Hahn, Fauci and Redfield Quarantine After Exposure

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FDA commissioner Stephen Hahn, CDC director Robert Redfield and NIH National Institute of Allergy and Infectious Diseases director...

ICU Medical Recalls Lactated Ringers Injection

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ICU Medical Recalls Lactated Ringers Injection

Daiichi Sankyo, AstraZeneca Breakthrough for Enhertu

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FDA grants Daiichi Sankyo and AstraZeneca a breakthrough therapy designation for Enhertu for treating patients with HER2 positive ...

Lilly Accelerated Approval for Retevmo

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FDA grants Eli Lilly accelerated approval three months ahead of schedule for Retevmo (selpercatinib) for certain patients with non...

First Covid-19 Antigen Test Gains Authorization

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FDA issues the first emergency use authorization for a Covid-19 antigen test Quidels Sofia 2 SARS Antigen FIA diagnostic test.

Singlera Genomics Colon Cancer Assay Pathway

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Singlera Genomics says it has completed a pre-submission meeting with CDRHs Office of In Vitro Diagnostics and it was provided cle...

FDA Withdrawing 7 ANDA Approvals

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Federal Register notice: FDA announces the approval withdrawal of seven ANDAs from multiple applicants after they notified the age...

Covid-19 Guidance Availability and Requested Comments

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Federal Register notice: FDA makes available guidance documents related to the coronavirus disease 2019 (Covid-19) public health e...

1st Saliva Home-collection Covid-19 Sample Authorized

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FDA grants Rutgers Clinical Genomics Laboratory an emergency use authorization for the first diagnostic test with the option of us...

Drug Outsourcing Firm Cited After Inspection

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FDA cites RC Outsourcing (Lowellville, OH) for GMP issues after the drug outsourcing facility was inspected in February.