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
Soficitinib is a potent and selective TYK2 inhibitor under development for multiple T-cell mediated autoimmune disorders
Abdomen-pelvis CT is the nation’s highest-volume CT category
This relates to the manufacture and supply of Human Recombinant Insulin (rh- Insulin) and Biosimilar Pegfilgrastim Drug Substance to the United States
Amrutanjan is also rolling out its new campaign, 'Har Dard Mitaye'
The audit was completed with zero critical and zero major observations
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