News
FDA approves new test for diagnosing gastroparesis.
On April 6, the U.S. Food and Drug Administration (FDA) approved Gastric Emptying Breath Test (GEBT), a new noninvasive test to help diagnose gastroparesis…
Infections associated with reprocessed duodenoscopes
The U.S. Food and Drug Administration (FDA) has taken several steps in response to infections associated with reprocessed duodenoscopes, including issuing a safety communication…
FDA approves new treatment for rare bile acid synthesis disorders
On March 17, the U.S. Food and Drug Administration (FDA) approved Cholbam (cholic acid) capsules, the first FDA-approved treatment for pediatric and adult patients…
FDA releases guidance on reprocessing reusable medical devices
On March 12, the U.S. Food and Drug Administration (FDA) released guidance that includes recommendations medical device manufacturers should follow for the safe and…
FDA approves CPR devices
On March 9 the U.S. Food and Drug Administration (FDA) approved the ResQCPR System, a system of two devices for first responders to use…
FDA approves first therapy for high-risk neuroblastoma
On March 10, the U.S. Food and Drug Administration (FDA) approved Unituxin (dinutuximab) as part of first-line therapy for pediatric patients with high-risk neuroblastoma.…
FDA launches drug shortages app
On March 4, the U.S. Food and Drug Administration (FDA) launched a free mobile app that identifies current drug shortages, resolved shortages, and discontinuations…
FDA approves system to permanently treat varicose veins
On February 20, the U.S. Food and Drug Administration (FDA) approved he VenaSeal closure system (VenaSeal system) to permanently treat varicose veins of the…
FDA approves Farydak for treatment of multiple myeloma
On February 23, the U.S. Food and Drug Administration (FDA) approved Farydak (panobinostat) for the treatment of patients with multiple myeloma. Read more.
FDA approves new test for diagnosing gastroparesis.
On April 6, the U.S. Food and Drug Administration (FDA) approved Gastric Emptying Breath Test (GEBT), a new noninvasive test to help…
Infections associated with reprocessed duodenoscopes
The U.S. Food and Drug Administration (FDA) has taken several steps in response to infections associated with reprocessed duodenoscopes, including issuing a…
FDA approves new treatment for rare bile acid synthesis disorders
On March 17, the U.S. Food and Drug Administration (FDA) approved Cholbam (cholic acid) capsules, the first FDA-approved treatment for pediatric and…
FDA releases guidance on reprocessing reusable medical devices
On March 12, the U.S. Food and Drug Administration (FDA) released guidance that includes recommendations medical device manufacturers should follow for the…
FDA approves CPR devices
On March 9 the U.S. Food and Drug Administration (FDA) approved the ResQCPR System, a system of two devices for first responders…
FDA approves first therapy for high-risk neuroblastoma
On March 10, the U.S. Food and Drug Administration (FDA) approved Unituxin (dinutuximab) as part of first-line therapy for pediatric patients with…
FDA launches drug shortages app
On March 4, the U.S. Food and Drug Administration (FDA) launched a free mobile app that identifies current drug shortages, resolved shortages,…
FDA approves system to permanently treat varicose veins
On February 20, the U.S. Food and Drug Administration (FDA) approved he VenaSeal closure system (VenaSeal system) to permanently treat varicose veins…
FDA approves Farydak for treatment of multiple myeloma
On February 23, the U.S. Food and Drug Administration (FDA) approved Farydak (panobinostat) for the treatment of patients with multiple myeloma. Read…
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