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FDA News Briefs for Thursday, December 20, 2018

December 20, 2018

These Food and Drug Administration (FDA) developments came in this week:


FDA Approves New Indication for Keytruda

On Wednesday, the FDA granted Keytruda (pembrolizumab; Merck) accelerated approval for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. More Information.


Lynparza Approved for First-Line Maintenance Therapy of BRCA-Mutated Ovarian Cancer

On December 19, 2018, the FDA expanded approval for Lynparza (olaparib; AstraZeneca) to include maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Patients should be selected for therapy based on an FDA-approved companion diagnostic. More Information.


Medtronic Issues Software Update for Puritan Bennett 980 Ventilator Series

Medtronic is notifying customers worldwide of a voluntary field corrective action for its Puritan Bennett 980 (PB980) ventilator series. The action is a software update to address customer feedback; it was initiated in September 2018. More Information.


Certain Dyural Convenience Kits Recalled

Asclemed USA Inc. is voluntarily recalling 20 lots of Dyural-40 and 61 lots of Dyural-80 convenience kits due to product labeling incorrectly stating stoppers do not contain latex. More Information.