Prescription Drug User Fee Act (PDUFA) goal date extended by three months for further review of submission to August 14, 2024 COPENHAGEN, Denmark, May 14, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma ...

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U.S. Food and Drug Administration FDA registered and inspected... Pharmaceuticals regulations, standardisation, control, concept ...

Can-Fite BioPharma Ltd. announces that the U.S. Food and Drug Administration has granted Investigational New Drug clearance for ...

Main outcome measures Postmarket safety actions defined as new label ... support by the US Food and Drug Administration, Arnold ...

The Food and Drug Administration is one ... to announce that the Investigational New Drug application for its BCMA CAR-T has ...

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 23 new drug applications (NDAs) from multiple applicants.

Granules announced that US Food & Drug Administration (US FDA) has approved its ANDA for Venlafaxine Hydrochloride Extended ...