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 ...

This new formulation provides an additional treatment option for pediatric and adult patients, making the therapy more accessible and convenient in tablet form. Evrysdi, marketed by Genentech ...

This new formulation provides an additional treatment option for pediatric and adult patients, making the therapy more accessible and convenient in tablet form. Evrysdi, marketed by Genentech, a Roche ...

(NASDAQ: EOLS), a performance beauty company with a focus on building an aesthetic portfolio, today announced that the U.S. Food and Drug Administration (FDA) has approved Evolysse™ Form and ...

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 ...

Launch Establishes Evolus as a Multi-Product Performance Beauty Company and Expands Addressable Market by 78% Evolus plans to launch Evolysse ™ Form and Evolysse ™ Smooth in the U.S. market in Q2 2025 ...

today celebrates the decision by the US Food and Drug Administration (FDA) to grant approval of a risdiplam (Evrysdi) in tablet form, marking a significant advancement in the treatment of spinal ...