Heron Therapeutics Inc.’s New Drug Application (NDA) was resubmitted to the U.S. Food and Drug Administration for HTX-011, an investigational agent for the management of postoperative pain.
Researchers called for more research into using blood from recovered Covid-19 patients – or so-called convalescent plasma – as a potential treatment, after a small trial of hospitalized patients in India found it was of no benefit.
A roundup of some of the latest scientific studies on the novel coronavirus and efforts to find treatments and vaccines includes a higher complication rate with Covid-19 versus the flu.
The Takeda Pharmaceutical Co.-led group that is developing a blood plasma treatment for Covid-19 started manufacturing while the late-stage trial to determine whether the hyperimmune globulin therapy works is ongoing, Chief Executive Christophe Weber said.
Japan’s Takeda Pharmaceutical said on Friday an alliance of drugmakers the company spearheads enrolled the first patient in a global clinical trial of a blood plasma treatment for Covid-19 after months of regulatory delays.
White House Reverses Course, Approves New FDA COVID-19 Vaccine Guidelines Published: Oct. 7, 2020 By Alex Keown BioSpace The White House has reversed its position on new vaccine guidelines proposed […]
The U.S. Food and Drug Administration is expected to issue a new and more stringent guidance regarding a potential Emergency Use Authorization (EUA) for a Covid–19 vaccine.
Vir Biotechnology and GlaxoSmithKline dosed the first patient in a Phase II/III clinical trial of VIR-7831, a fully human monoclonal antibody against Covid-19.
The U.S. Food and Drug Administration authorized the use of blood plasma from patients who have recovered from Covid-19 as a treatment for the disease.
The U.S. Food and Drug Administration placed a hold on the Emergency Use Authorization for convalescent plasma as a potential treatment for Covid-19 over what was described as a lack of robust data supporting its use.
