First-In-Class Drugs Made Up More Than Half Of US FDA’s Novel Approvals Last Year
CDER hit a high mark with 27 first-in-class approvals in the 50 novel agents cleared in 2021.
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Patients in the UK with generalized myasthenia gravis are being allowed to receive argenx’s yet-to-be approved drug efgartigimod.
Biotech stock indices have seen a recent recovery but remain well below their 2021 peaks raising questions about the likelihood of raising money for R&D. The number of companies announcing leadership changes, shifting pipeline priorities and job cuts is rising as a result.
Accelerated Approval Makes Big Splash In 2021 Novel Agents, Despite Crackdown On ‘Dangling’ Cancer Claims
US FDA’s accelerated approvals hit a contemporary high in 2021, accounting for one-third of novel US approvals, but the big story was the agency’s crackdown on delinquent confirmatory trials for oncology AA indications.