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EUA for Gohibic for Some Hospitalized Covid Patients

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FDA approves an emergency use authorization for InflaRxs Gohibic to treat some hospitalized Covid-19 patients.

FDA on Pharmacodynamic Biomarker Research

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FDA outlines research into potential pharmacodynamic biomarkers for biosimilar development.

Docket Open for Opioids Home Disposal REMS

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Federal Register notice: FDA establishes a docket to obtain information and comments to help assess whether in-home disposal produ...

FDA Selecting Fall Covid Vaccine Make-up in June

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CBER director Peter Marks says Covid-19 vaccine makers will be given advice in June on the next booster vaccine composition for fa...

Phathom Plans to Resubmit NDA, and Supplemental NDA

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Phathom Pharmaceuticals says it will resubmit an NDA for vonoprazan for treating erosive esophagitis, and a post-approval suppleme...

2 Pfizer sNDA Submitted for Lung Cancer Drugs

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FDA accepts for review two Pfizer Supplemental NDAs for Braftovi (encorafenib) and Mektovi (binimetinib) and their use in patients...

BC3 Tech Clears SEAL Rapid Wound Spray

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FDA clears a BC3 Technologies 510(k) for its SEAL Hemostatic Wound Spray.

Opioid Makers Must Provide Mail-back Envelope

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FDA says it is requiring opioid analgesic manufacturers to make prepaid mail-back envelopes available to outpatient pharmacies and...

Untitled Letter to Minneapolis Regenerative Medicine

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CBERs Office of Compliance and Biologics Quality sends an untitled letter to Minneapolis Regenerative Medicine over claims made on...

De Novo Granted to Sleeping Infant Device

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FDA grants a de novo marketing authorization to Happiest Baby for its SNOO, a medical device for keeping sleeping babies safely on...