US FDA’s Best Year Ever For New Drugs: CDER Novel Approvals Hit 59
FDA’s drug center smashes its past records for new molecular entities and therapeutic biologic approvals; with five novel biologics approved by FDA’s biologics center, the agency’s novel approvals reach a stunning total of 64.
You may also be interested in...
US FDA Ends 2019 With Second-Highest Approval Count After Second-Half Rebound
CDER's 48 novel agents, including 35 in the second half of the year, marks the second-highest novel approval count in the contemporary era.
How Much Can Trump’s Childhood Cancer Funding Proposal Boost Drug Approvals?
President Trump’s 2019 State of the Union Address broadly touched on the themes of funding childhood cancer research, drug pricing and eliminating HIV.
Hazards Ahead For New Drugs At US FDA Amid Safety Concerns, Shutdown Disruption
The pipeline for new drug candidates remains healthy as 2019 begins, with almost 40 novel agents already under FDA review. But the chances of another record-breaking year are threatened by a confluence of safety issues that are putting risk management back in the spotlight – and by the widening ripple effects of the recent US government shutdown.