Milestone also announced the extension of its $75 million Royalty Purchase Agreement with RTW Investments
The FDA set a target action date of April 28, 2026, under the Prescription Drug User Fee Act
If approved, linerixibat could address high unmet medical need of patients living with cholestatic pruritus (relentless itch) and related sleep interference
The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date
Zongertinib would be the first orally administered, targeted therapy for previously treated patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC), if approved
Recommendation based on results of Phase 3 CheckMate -9DW clinical trial demonstrating statistically significant and clinically meaningful improvement in overall survival with Opdivo plus Yervoy compared to investigator’s choice of lenvatinib or sorafenib in this patient population
The company is committed to unlocking new frontiers in neuroscience and developing Usnoflast for patients with ALS
Olanzapine is indicated for the acute and maintenance treatment of schizophrenia and related psychotic disorders
Menkes disease is a rare X-linked recessive pediatric disease caused by gene mutations of the copper transporter ATP7A
These three NDAs of Sitagliptin (base) and combination franchise have been approved by the USFDA earlier through the 505(b)(2) route
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