FDA
Eli Lilly’s Jardiance scores expanded heart failure approval from the FDA and will now be available to all patients with heart failure to reduce the risk of death and hospitalization.
FEATURED STORIES
Priority voucher awardees and regulators could feel pressure to “meet the moment” as FDA watchers question the intent and feasibility of the Commissioner’s National Priority Voucher program.
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.
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BioCryst Pharmaceuticals, Inc. announced on Thursday that the U.S. Food and Drug Administration (FDA) has approved ORLADEYO (berotralstat) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and young patients 12 years and older.
The U.S. Food and Drug Administration has given Emergency Use Authorization (EUA) to a COVID-19 test developed by Roche that measures antibodies within the blood.
The U.S. FDA approved Genentech and Blueprint Medicines’ Gavreto as a treatment for adults and pediatric patients 12 and above who have been diagnosed with rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC).
The FDA uses special designations to get new, breakthrough treatments to patients in the greatest need.
The FDA approval was based on results from the largest studies conducted to date in obesity associated with POMC, PCSK1 or LEPR deficiency.
Despite the constant need for social distancing, mask-wearing, and the isolation and economic uncertainty that resulted from the outbreak, there is still much to be thankful for when families gather around a virtual table to break bread and carve the turkey this year.
Genentech’s influenza treatment Xofluza® (baloxavir marboxil) has been granted approval by the U.S. Food and Drug Administration for use in people 12 years and older, making it the first single-dose post-exposure prophylaxis strategy approved by the agency.
The U.S. FDA approved Alnylam Pharmaceuticals’ Oxlumo (lumasiran) for primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in children and adults.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for November 24, 2020.
Eiger’s Zokinvy is the first-ever approved treatment for children with Huchinson-Gilford Progeria Syndrome and processing-deficient Progeroid Laminopathies.