Trinidad-based OTC drug manufacturer CGA drew a warning letter from the FDA for serious GMP lapses including inadequate testing and producing an unapproved drug.

Trials for hematologic malignancies can use measures of minimal residual disease (MRD) as a biomarker, according to a final guidance issued by the FDA that specifies the types and uses of measures the agency will accept.

Gilead fired back at HHS’s patent infringement suit over its HIV drugs Truvada and Descovy, claiming that the patents the department is suing over are invalid.