FDA
Eli Lilly’s proposed antibody drug bebtelovimab has received EUA from the FDA after demonstrating its potency against SARS-CoV-2’s Omicron variant.
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.
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for October 27, 2020.
After discovering promising indicators on the path to the development of Branaplam (LMIO70) for spinal muscular atrophy, Novartis now hopes to repurpose the drug for the treatment of Hungtington’s disease.
Shares of Gilead Sciences are jumping in aftermarket trading following full approval for Veklury (remdesivir) as a treatment for COVID-19. The approval marks the first drug approved by the U.S. Food and Drug Administration as a treatment for the novel coronavirus.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for October 20, 2020.
The U.S. FDA granted Roche’s Venclexta (venetoclax) full approval in combination with azacytidine, or decitabine, or low-dose cytarabine for newly diagnosed acute myeloid leukemia in adults 75 years or older.
The U.S. Food and Drug Administration has several PDUFA dates for the rest of October, although two of them were already approved. Here’s a look.
Regeneron announced that the U.S. Food and Drug Administration approved Inmazeb, a three-antibody cocktail to treat Ebola infections in adults and children.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for October 13, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for October 6, 2020.
The new high-speed test uses a high-throughput method comprising heat and technology to extract RNA from samples used for COVID-19 RT-PCR molecular testing.