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June 13, 2016
FDA approved Vaxchora intended for travelers who are at risk for the disease.
June 10, 2016
Mandatory use of the periodic safety update report repository becomes mandatory on June 13.
June 09, 2016
The agency publishes three final guidance documents on drug compounding.
June 06, 2016
The agency reiterated its earlier decision to require suffixes in biosimilar naming, but was unclear on suffix meaning.
June 02, 2016
FDA and bio/pharma companies get serious about continuous manufacturing to ensure product quality.
FDA approved dalizumab a monoclonal antibody for the treatment of multiple sclerosis.
June 01, 2016
FDA issues a warning letter to Megafine Pharma Limited for data integrity violations.
May 31, 2016
FDA approved Probuphine, the first buprenorphine implant approved in the United States for the treatment of opioid dependence.
The agency publishes draft guidance on assessing the adhesion of transdermal delivery systems and topical patches.
Samsung Bioepis and partner Biogen announced on May 30 that the European Commission approved Flixabi for the treatment of six inflammatory conditions.