Ascendis Pharma’s FDA review of Achondroplasia drug gets 3-month delay
The FDA has classified recent submissions as a major amendment pushing the approval to its NDA for TransCon CNP back three months to February 28, 2026
The FDA has classified recent submissions as a major amendment pushing the approval to its NDA for TransCon CNP back three months to February 28, 2026
The oral, film-coated tablet is licensed for patients whose cancer has returned during or shortly after hormone therapy
Nitrosamines have prompted evolving global guidelines that demand rigorous industry oversight
CD388 is administered as a single 450-milligram subcutaneous dose in adults and adolescents
It's a development that marks a major step forward for patients struggling with moderate-to-severe chronic spontaneous urticaria
Clinical trials found that 77% of patients went into remission after receiving obe-cel
Surgical site infections and antimicrobial resistance remain major challenges globally
Itvisma is a one-time, fixed-dose therapy designed to tackle the genetic root cause of SMA
The deliveries bring the innovative medicine to communities heavily impacted by HIV just five months after U.S. FDA approval
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