Rosetta Genomics, Ltd.
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Latest From Rosetta Genomics, Ltd.
Cancer, Gene Therapy Top US FDA’s Second Half 2024 User Fee Calendar
Novel agents in immuno-oncology headline the drug center’s upcoming goal dates, while gene therapies make up most of the biologic center’s workload.
FDA’s Dry January: Little Novel Application Activity, But That Doesn’t Mean No Fun
US FDA’s drugs center posted one of its lowest monthly approval counts of original applications in January, but new indications filled the gap, including new claims for Merck’s Keytruda, Takeda immunoglobulins, and Sanofi/Regeneron’s Dupixent.
As 2024 Begins, US FDA’s Novel Agent Prospects Look A Lot Like 2023
Immuno-oncology will remain a major force at both FDA’s drugs and biologics centers, but watch for psychiatry and antibiotics to make some noise; rare pediatric diseases will remain prominent as the priority review voucher program heads into the sunset.
Keeping Track: Opdivo, Keytruda Continue Adjuvant Push As Cancer Dominates Recent Applications
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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