News
FDA approves Raplixa to help control bleeding during surgery
On April 30, the U.S. Food and Drug Administration (FDA) approved Raplixa (fibrin sealant [human]), the first spray-dried fibrin sealant approved by the agency.…
FDA approves generic Abilify
On April 28, the U.S. Food and Drug Administration (FDA) approved the first generic versions of Abilify (aripiprazole). 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 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 approves Raplixa to help control bleeding during surgery
On April 30, the U.S. Food and Drug Administration (FDA) approved Raplixa (fibrin sealant [human]), the first spray-dried fibrin sealant approved by…
FDA approves generic Abilify
On April 28, the U.S. Food and Drug Administration (FDA) approved the first generic versions of Abilify (aripiprazole). 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…