Regulatory
The U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug application that will allow Boston-based Vertex Pharmaceuticals to proceed with a clinical trial of its investigational stem cell-derived, fully differentiated pancreatic islet cell treatment for type 1 diabetes (T1D).
February is kicking off with a number of PDUFA dates for the U.S. FDA as well as a cancer advisory committee meeting. Here’s a look.
The decision by the FDA on the drug application was expected on March 7, but is now delayed until June 7, 2021.
The FDA is on a roll granting approvals. Three companies announced IND updates today.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for January 26, 2021.
Pfizer, Moderna, AstraZeneca, and Johnson & Johnson all have trials of their respective vaccines underway in various age-groups.
AstraZeneca spinout Albireo Pharma is moving closer to securing regulatory approval for its treatment known as odevixibat, for pruritus in patients with PFIC.
The drug, a combination of cabotegravir and rilpivirine, is a complete therapy for HIV-1 infection in adults who are virologically suppressed.
The U.S. FDA has accepted Genentech’s supplemental New Drug Application and has granted Priority Review for the company’s unclassifiable interstitial lung disease (UILD) treatment Esbriet® (pirfenidone).
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for January 19, 2021.
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