FDA Related News

Human Drugs

FDA Approves Darzalex Faspro for Myeloma

FDA approves Janssens Darzalex Faspro plus Kyprolis and dexamethasone to treat some multiple myelomas.

Human Drugs

GDUFA Science and Research Priority Initiatives

FDA publishes 15 GDUFA scientific and research priorities for FY 2022.

Human Drugs

CTI BioPharma Myelofibrosis NDA Review Extended

FDA extends by three months its review of a CTI BioPharma NDA for treating adult patients with intermediate or high-risk primary or secondary myelofib...

Human Drugs

FDA Lifts Entolimod Clinical Hold

FDA lifts its clinical hold on Statera Biopharmas entolimod for treating acute radiation syndrome.

Medical Devices

FDA Updates Cybersecurity Information

FDA adds four items to its online medical device cybersecurity page.

Medical Devices

FDA Monitoring NuVasive Device Concerns

FDA says the benefits of NuInvasive titanium-based Precice devices continue to outweigh the known risks with updated labeling in place.

Human Drugs

Immunexpress Rapid Sepsis Diagnostic Cleared

FDA clears an Immunexpress 510(k) for its SeptiCyte Rapid, a diagnostic aid for use in differentiating sepsis from infection-negative systemic inflamm...

Biologics

FDA Puts Clinical Hold on Ocugen Covid Vaccine

FDA issues a clinical hold for undisclosed reasons on an Ocugen IND intended to evaluate the companys Covid-19 vaccine candidate, BBV152, which is kno...

Concerns About FDA Drug/Device Reclassifications Aired

Stakeholders express concerns about an FDA decision in response to an appeals court ruling to reclassify some drugs as drug-led combination products.

Medical Devices

QS Violations at Invacare Facilities

FDA warns Invacare about QS violations found in inspections at three of its oxygen concentrator manufacturing facilities.