Submit Questions: Prepare a list of specific questions for the FDA regarding your IND submission. Form FDA 1571 Complete Form FDA 1571: Ensure all sections are filled out accurately, including sponsor ...

The U.S. Food and Drug Administration has approved a new drug application for a tablet version of Evrysdi (risdiplam) for people living with spinal muscular atrophy (SMA). The new tablet is ...

Piramal Pharma slipped 1.14% to Rs 195.40 after the US FDA issued a Form-483 with 6 observations to the company's Turbhe facility post a GMP inspection. In a regulatory filing made after market hours ...

TUESDAY, Feb. 18, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has approved a new drug application for a tablet version of Evrysdi (risdiplam) for people living with spinal muscular ...

Probationary employees across the FDA received notices Saturday evening that their jobs were being eliminated, according to three FDA staffers who spoke to The Associated Press on condition of ...

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Background: Prevention programs often promote HIV testing as one possible strategy of combating the spread of the disease. Objective: To examine levels of HIV testing practices among a large ...

Drug major Cipla reported a 49% year-on-year jump in its December quarter consolidated net profit, reaching Rs 1,571 crore, compared to Rs 1,056 crore in the same period last year. The profit after ...