Government
The end of February and beginning of March is a busy time for the U.S. Food and Drug Administration, with a number of PDUFA dates on the calendar.
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. FDA approved Sarepta Therapeutics’ Amondys 45 (casimersen) for patients with Duchenne muscular dystrophy (DMD) who have a confirmed mutation amenable to exon 45 skipping.
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.
Although problems with actually getting shots into arms have been described thoroughly, manufacturing problems and scale-up haven’t been the focus of much reporting.
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.
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