Fosamax further defines the obligation of drug manufacturers to present clear, unambiguous, and accurate information to the ...

In particular, the plaintiffs contended that Merck should have added safety warnings to its Gardasil label in 2011 and 2013 ... that is slated to crank out bulk drug substance for Gardasil.

Merck (NYSE:MRK) announced Wednesday that the U.S. Food and Drug Administration (FDA) approved a label expansion for its blockbuster therapy Keytruda to allow its use as a first-line combination ...

Merck KGaA fought for years to get the drug approved after rejection by the ... risk of cancer and birth defects, as well as a label that only supports second-line use of the drug.

U.S. District Judge Kenneth Bell, who is overseeing the Gardasil multidistrict litigation in the Western District of North Carolina, sided with Merck on its implied preemption defense, granting ...

Merck plans to begin submitting applications ... to decrease in total lymphocyte and/or CD4 counts. In this open-label study, drug-related AEs were more commonly reported with DOR/ISL (n=44 ...

Merck (NYSE:MRK) said that data from a pair of late-stage trials showed that an oral, two-drug regimen of doravirine ... In the second trial, which was open label, 95.6% of participants who ...