This is the first time in history that an NDA for a New Chemical Entity (NCE) from an Indian pharmaceutical company has been filed and accepted by the USFDA
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 study, which enrolled 35 Japanese patients, evaluated the percent change from baseline in the 24-hour urine protein-to-creatinine ratio
The drug, intended for chronic weight management alongside diet and exercise, is now under the FDA’s new CNPV expedited review pathway
Sac-TMT is a novel human TROP2 ADC with proprietary intellectual property, targeting advanced solid tumors
Centanafadine is a first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor
Loperamide Hydrochloride is an anti-diarrheal medication used to control symptoms of acute and chronic diarrhoea
Tofacitinib extended-release tablets are a Janus kinase inhibitor indicated for Rheumatoid Arthritis
Innovent plans to soon submit a new drug application (NDA) to China’s National Medical Products Administration
HER2-mutant NSCLC typically has a poor prognosis and limited treatment options
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