Phase III
Spero Therapeutics received a Complete Response Letter from the U.S. Food and Drug Administration for its complicated urinary tract infection therapy, tebipenem HBr oral tablets.
MindMed, Scripps Research, Cingulate Therapeutics and the University of Pennsylvania discuss innovative treatments on the horizon for the treatment of anxiety disorder.
For the first time in two years, the European Association for the Study of the Liver’s International Liver Congress was back on-site with cutting-edge research in hepatology and other sectors.
BMS’ CAR-T therapy Breyanzi picked up a second approval from the FDA. The cancer drug was approved for the treatment of adult patients with large B-cell lymphoma.
Otsuka Pharmaceutical and Lundbeck announced positive Phase III clinical trial results Monday regarding brexpiprazole (Rexulti) as a treatment for agitation in patients with Alzheimer’s dementia.
Ipsen announced it is acquiring the company and its cancer drugs, including Tazverik, which were approved for two different indications by the FDA in 2020.
The current vaccinations still offer significant protection against severe diseases. Meanwhile, vaccine companies are progressing in designing and testing Omicron-specific booster shots.
While it was a relatively quiet week for clinical trial announcements overall, BioSpace takes a look at some of the more intriguing ones.
Amryt Pharma is filing a formal dispute resolution request (FDRR) with the FDA after receiving a CRL that delays the production of its drug for a rare skin disorder.
Positive news continues for COVID-19 vaccine development and distribution, with Sanofi and GSK announcing the success of their candidate against the Omicron variant.
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