FDA
The company added an indication to Lynparza’s label for the treatment of adults with metastatic castration-resistant prostate cancer, while cutting an antibody for Crohn’s disease and ulcerative colitis.
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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Recent FDA approval of ViiV Healthcare’s HIV treatment Cabenuva reduced dosing to once every two months.
Novavax is finally submitting an Emergency Use Authorization request to the U.S. Food and Drug Administration for its COVID-19 vaccine candidate, NVX-CoV2373, a protein-based vaccine.
The FDA’s decision is based on positive results from several Phase III studies, including the TENAYA and LUCERNE clinical trials.
The FDA approved Kimmtrak for the treatment of HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma (mUM).
The FDA cited data demonstrating that both treatments are not likely to be potent against omicron and should not be authorized for use in any U.S. state, territory, and jurisdiction for the time being.
It’s a landmark no one expected or wanted — more than 70 million confirmed COVID-19 cases in the U.S. with 866,000 deaths. For that and more COVID-19 news, continue reading.
The U.S. Food and Drug Administration has approved SKYRIZI (risankizumab-rzaa), AbbVie’s proposed treatment for adults diagnosed with active psoriatic arthritis (PsA).
After receiving daily doses of the therapeutic, 71% of the children could tolerate the equivalent of 16 peanuts and six months later, 21% of them still could.
The FDA has lifted the partial hold on Kura Oncology’s KOMET-001 Phase IB trial on a potential treatment for acute myeloid leukemia.
Expanded approval for Rinvoq was based on three Phase III studies that included more than 2,500 patients. The studies met all primary and secondary endpoints.