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
This relates to the manufacture and supply of Human Recombinant Insulin (rh- Insulin) and Biosimilar Pegfilgrastim Drug Substance to the United States
The receipt of this order further strengthens the company's position in the global pharmaceutical market
GLP-1 therapies are among the fastest-growing drug classes worldwide, projected to drive a $95 billion obesity market by 2030
Most recently, Yuvraj was the Director of Operations, Business Development & Process Excellence at Zeon Lifesciences Ltd
The drug, intended for chronic weight management alongside diet and exercise, is now under the FDA’s new CNPV expedited review pathway
Centanafadine is a first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor
The trial tested six injectable doses and three oral doses over as long as 36 weeks
The deliveries bring the innovative medicine to communities heavily impacted by HIV just five months after U.S. FDA approval
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