03/02/2015 - 4:56pm

The FDA is expected to issue new guidance on biosimilars labeling and generic opioids before the end of year, according to a report by the Regulatory Affairs Professional Society.

03/02/2015 - 1:08pm

The implementation of an e-prescribing mandate in New York hits a snag as state legislators agree to a delay.

02/27/2015 - 11:29am

ACIP on Thursday recommended that children ages 6 months and older get an annual influenza vaccine with no preference stated for either the nasal spray vaccine or the flu shot.

02/26/2015 - 6:05pm

Congress introdues legislation to protect FDA user fees from sequestration. 

02/26/2015 - 4:26pm

The CDC’s Advisory Committee on Immunization Practices made a unanimous recommendation for use of meningococcal group B vaccines to vaccinate high-risk groups in the United States.

02/26/2015 - 1:53pm

Sanofi expands its portfolio of insulin therapy products with the introduction of the once-daily, long-acting Toujeo. 

02/26/2015 - 12:43pm

The fixed-combination drug Avycaz was granted priority review by the Food and Drug Administration. 

02/26/2015 - 12:39pm

The National Association of Chain Drug Stores has submitted a statement to the U.S. House Committee on Energy and Commerce Subcommittee on Health expressing concerns about pharmacy-related budget proposals.

02/24/2015 - 4:10pm

The Food and Drug Administration is looking into enabling holders of abbreviated new drug applications to unilaterally update their generic drug product labels prior to any branded drug change.