With more than 60 novel drug and biologic candidates already under review, the potential class of 2021 has bursts of activity in therapy areas that have been quiet in recent years – notably dermatology and liver and kidney disease – alongside a full pipeline in recent stalwarts like oncology and neurology.
What Pandemic Effect? US FDA’s 2021 Approval Class Is Off To Strong Start With 60+ Novel Candidates
Dermatology, chronic kidney disease and liver disease therapies stand out in a crowd of user fee goals that is actually bigger than at the same point in 2020.
More from Approvals
More from Product Reviews
• By
Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.
• By
The European Medicines Agency’s qualification of the AIM-NASH tool is said to signify a major advancement for clinical trials for metabolic dysfunction-associated steatohepatitis. The market size for MASH treatments is expected to grow substantially in the coming years.
• By
Novartis is planning to file EU and US marketing applications for an intrathecal formulation of its spinal muscular atrophy gene therapy, Zolgensma, in H1 2025.