FDA grants orphan drug status to NeuroVive Pharma NeuroSTAT
The ODD covers both open and closed moderate to severe traumatic brain injury and gives NeuroVive Pharma market exclusivity for NeuroSTAT in the US for seven years from
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to Eli Lilly and Company’s (Lilly) olomorasib as a potential treatment for adults with advanced pancreatic cancer who have already received at least one prior systemic therapy.
The study measured improvements in patients with predominantly negative symptoms of schizophrenia who received RG1678 in combination with second-generation antipsychotics. Genentech said that RG1678 was generally well tolerated