Plus   Neg

Merck Files Six SBLAs To Update Dosing Frequency For KEYTRUDA - Quick Facts

Merck (MRK) said the FDA has accepted for review six supplemental Biologics License Applications (sBLAs) to update the dosing frequency for KEYTRUDA, to include an every-six-weeks dosing schedule option for melanoma and other indications. If approved, KEYTRUDA 400 mg every-six-week dosing option would be available for use in adults in addition to the currently approved dose of 200 mg every-three-week option. The FDA has set a PDUFA date of Feb. 18, 2020.

In the European Union, 400 mg every-six-week dosing for KEYTRUDA monotherapy was approved in March.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
The U.S. Food and Drug Administration or FDA announced on its website that pharma major Pfizer, Inc. issued recall of two lots of tablets meant to treat acute migraine in adults for concerns over bacteria infection. The pharma company is recalling two lots of Relpax (eletriptan hydrobromide) 40 mg tablets for potential presence of Genus Pseudomonas and Burkholderia bacteria. Cosmetics company Revlon Inc. (REV) is reportedly considering a potential sale of parts or all of its business. According to Bloomberg, Revlon has retained financial advisers from Goldman Sachs Group Inc. to explore strategic alternatives. No deal has been reached yet, but Revlon is exploring all... China's Lenovo Group Ltd. warned it may have to raise prices of its products if the U.S. moves ahead with the decision to impose additional tariffs on Chinese goods, according to a report by Reuters. The warning by Lenovo, the world's largest PC maker, comes amid the escalating trade war between the U.S. and China that has raised concerns about the global economic outlook.
Follow RTT