FDA refuses to file Savara BLA for Molbreevi
Texas, USA-based clinical-stage biopharma Savara (Nasdaq: SVRA) on Tuesday announced that the company received a refuse to file (RTF) letter from the US Food and Drug Administration (FDA) for the biologics license application (BLA) of Molbreevi (molgramostim) as a therapy to treat patients with autoimmune pulmonary alveolar proteinosis (PAP), with the news sending its shares plunging 32% to $1.94.
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