Regulatory
Passage Bio’s first attempt to develop a GM1 gangliosidosis gene therapy treatment has run into a roadblock in the form of a clinical hold.
The U.S. Food and Drug Administration (FDA) approved another therapy for Duchenne muscular dystrophy (DMD), this time NS Pharma’s Viltepso (viltolarsen).
Olinvyk is indicated for short-term intravenous use in hospitals or other controlled clinical settings, such as during inpatient and outpatient procedures.
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Genentech, a Roche company, announced the U.S. Food and Drug Administration (FDA) had approved its Evrysdi (risdiplam) for spinal muscular atrophy (SMA) in adults and children two months of age and older.
The FDA set a PDUFA target date of March 7, 2021 for aducanumab, Biogen said.
Although August is a busy month on the U.S. Food and Drug Administration (FDA)’s calendar for PDUFA dates, this week’s dates were almost all approved ahead of schedule. Here’s a look.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 7, 2020.
Blenrep is GSK’s second regulatory approval in four months. GlaxoSmithKline is once again making its mark as an oncology-focused pharmaceutical company.
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