FDA
Thursday, the FDA greenlit Ostuka and Lundbeck’s Rexulti as the first treatment in the U.S. for agitation associated with dementia due to Alzheimer’s disease.
FEATURED STORIES
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
One of the FDA’s potential approvals this month could break an existing monopoly in the treatment space for a rare growth disorder.
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The U.S. Food and Drug Administration is wrapping up 2021 with a fairly busy schedule for the month of December. Here’s a look at the first half of the month.
This afternoon, the U.S. Food and Drug Administration expanded the Emergency Use Authorization for Eli Lilly’s monoclonal antibody treatment combination of bamlanivimab and etesevimab.
The approval was based on Phase II data from the PLEIADES study that showed patients treated with the combination therapy generated an overall response rate of 84.8%.
The FDA’s decision is based on positive results from two Phase III trials, the PROTECT and CONSTANT, on the drug’s efficacy.
Sigilon Therapeutics announced it may have discovered the reason why its experimental cell therapy treatment for severe hemophilia A was placed on clinical hold by the FDA.
Results from its GEM-3 trial on VYJUVEK demonstrated statistical significance in its ability to promote complete wound healing within six months compared to a placebo.
The U.S. Food and Drug Administration has a very busy calendar for the end of November and beginning of December. Here’s a look.
The FDA approved Takeda’s Livtencity (maribavir) for adults and children 12 years or older with post-transplant cytomegalovirus (CMV) infection.
Shares of Aadi Bioscience were up more than 25% in premarket trading after announcing the FDA greenlit its treatment for a rare and aggressive form of cancer that disproportionately affects women.
The FDA has granted Cambridge-based bluebird Bio a Priority Review of its Biologics License Application for betibeglogene autotemcel (beti-cel).