Food and Drug Administration (FDA)
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Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 10, 2020.
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.
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.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 5, 2020.
In its CRL, the FDA identified concerns regarding the impact of patch-site adhesion on efficacy and indicated the need for patch modifications.
August is a busy month on the U.S. Food and Drug Administration (FDA)’s calendar. Here’s a look at this week’s schedule.
The U.S. FDA issued a new template for clinical test developers that is designed to assist these companies in developing and submitting emergency use authorization (EUA) for COVID-19 tests that can be performed at home or in other settings besides laboratories.
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