Food and Drug Administration (FDA)
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The company has agreed to deliver 100 million doses of the vaccines by the end of June.
On Thursday, the company said the U.S. Food and Drug Administration wants to see additional data beyond the Phase III study announced last year.
The U.S. Food and Drug Administration has approved AbbVie’s biologic therapy HUMIRA® (adalimumab) as a treatment for moderate-to-severe active ulcerative colitis in children aged 5 years and older.
The hold comes just after patient dosing began in HGB-210, the company’s Phase III single-arm open-label LentiGlobin trial for SCD patients between the ages of 2 and 50.
The date set by the FDA’s independent advisors for debating that decision is Friday, February 26.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for February 23, 2021.
On Monday, the companies announced their checkpoint inhibitor Libtayo (cemiplimab-rwlc) won Food and Drug Administration approval for lung cancer.
The U.S. FDA issued new guidance for vaccine makers as it is preparing for the possibility of needing to approve COVID-19 booster shots against variants of the SARS-CoV-2 virus.
Otezla, an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) directed for cyclic adenosine monophosphate (cAMP), may indirectly modulate inflammatory mediators in certain conditions, but the specific underlying mechanisms are not clearly understood.
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