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Integra LifeSciences Removes CereLink Intracranial Monitors

[ Price : $8.95]

Integra LifeSciences begins a global product removal of all CereLink intracranial pressure monitors after customer reports were re...

Incytes Pemazyre OKd for Rare Blood Cancer

[ Price : $8.95]

FDA approves an Incyte supplemental NDA for Pemazyre (pemigatinib), a selective fibroblast growth factor receptor inhibitor for tr...

Medtronic HVAD Battery Recall is Class 1

[ Price : $8.95]

FDA says the Medtronic recall of HVAD batteries for electrical faults is Class 1.

FDA Unit Reports High State of Pharmaceutical Quality

[ Price : $8.95]

CDERs Office of Pharmaceutical Quality issues an upbeat outlook for drug quality in its FY 2021 annual report, with data on drug m...

Novartis Suspends Dosing in Branapalm Trial

[ Price : $8.95]

Novartis says it is suspending branapalm dosing in a Phase 2b trial of the drug in adults with Huntingtons Disease due to side eff...

Iovance Biotherapeutics BLA for Melanoma Therapy

[ Price : $8.95]

Iovance Biotherapeutics initiates a rolling BLA for lifileucel, a tumor infiltrating lymphocyte therapy for use in patients with a...

CGMP Violations at Oregons Wild Harvest

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FDA warns Redmond, OR-based Oregons Wild Harvest about CGMP violations in its manufacturing, packaging, labeling, and holding of d...

Steps Toward Drug Quality Knowledge Management System

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Several international pharmaceutical regulatory organizations, including FDA, issue a joint reflection paper on efforts toward bui...

Positive Results in Pfizer RSV Vaccine Trial

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Pfizer says it will seek regulatory approval this fall for its respiratory syncytial virus prefusion F vaccine candidate.

Medical Device Export Information Collection

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Federal Register notice: FDA sends to OMB an information collection extension entitled Export of Medical Devices; Foreign Letters ...