FDA Related News

Medical Devices

EUA for Cepheid Xpert Mpox Test

FDA issues an emergency use authorization for the Cepheid Xpert Mpox test for use in a point-of-care setting for detecting monkeypox.

Human Drugs

Pfizer Expanded Indication for Cibinqo in Adolescents

FDA approves a Pfizer supplemental NDA for Cibinqo (abrocitinib), expanding its indication to include adolescents (12 to 18 years) with refractory, mo...

Federal Register

FDA Withdrawals Emergent Narcan sNDA

Federal Register notice: FDA withdraws the approval of an Emergent Biosolutions supplemental NDA for Narcan (naloxone hydrochloride 2 mg/.1 ml) after ...

HHS Roadmap Outlines FDA Flexibilities Post-Covid

An HHS Covid-19 Public Health Emergency Transition Roadmap outlines FDAs flexibilities and actions that will not be affected after the health emergenc...

Human Drugs

Phathom Gets 2 Complete Response Letters Over Impurity

FDA issues two complete response letters to Phathom Pharmaceuticals one for an NDA for vonoprazan for treating erosive esophagitis, and the other for...

FDA to Explain Post-Health Emergency Effects

Ropes & Gray attorneys explain the impact of the upcoming termination of the Covid-19 public health emergency on FDA guidances and policies.

Medical Devices

GE Nuclear Medicine System Recall is Class 1

FDA says the GE Healthcare 12/19/22 recall of nuclear medicine systems is Class 1.

Human Drugs

Eiger Wont Seek EUA for Interferon Covid Treatment: Bloomberg

Bloomberg reports that experts are debating the value of therapeutics like Eigers lambda peginterferon against Covid.

Human Drugs

Eylea Approved for Infants with Retinopathy

FDA approves Regeneron Pharmaceuticals Eylea (aflibercept) injection to treat preterm infants with retinopathy of prematurity.

Medical Devices

FDA Updates Philips MDRs; 82 Deaths in 2 Months

FDA updates an ongoing safety communication on Philips Respironics ventilators, BiPAP machines, and CPAP machines to provide information about medical...