OR WAIT null SECS
June 22, 2016
OPKO’s newly approved extended-release capsule uses Catalent’s OptiShell softgel capsule technology.
June 20, 2016
Emergent is seeking approval for the manufacture of BioThrax at the company’s large-scale manufacturing facility.
June 16, 2016
The agency provides quality, development, manufacturing, and labeling recommendations.
June 06, 2016
The agency published a report on fostering the development of advanced therapy medicinal products.
June 02, 2016
FDA approved dalizumab a monoclonal antibody for the treatment of multiple sclerosis.
During its May 2016 meeting the CHMP recommended the approval of six medications in the EU, including three generic drugs, treatments for hepatitis C, and Type 2 diabetes.
May 31, 2016
FDA approved Probuphine, the first buprenorphine implant approved in the United States for the treatment of opioid dependence.
May 25, 2016
Sandoz is seeking approval for the same indications as Roche’s reference product MabThera.
May 24, 2016
FDA accepted for review Samsung Bioepis’ BLA for SB2, a biosimilar to Remicade (infliximab).
May 02, 2016
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to report quality metrics to FDA.