First-in-Class: 2014 Drug Approvals

The FDA ushered in six new drugs just before the close of 2014, bringing the final tally to 41– the highest rate since 1996, when the agency approved 53 drugs. 2014 drug approvals were notable not only for their quantity, but also their quality. A number of new drugs...

The Bispecific Antibody: A Lethal Hybrid

Amgen’s acute lymphoblastic leukemia treatment, Blincyto, coasted past the FDA bottleneck ahead of schedule, gaining approval earlier this month as a “first of its kind” immunotherapy. The FDA designated Blincyto as a breakthrough therapy and an orphan product on top...