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Flu season is here and overall viral activity is up 23% across the United States, even as respiratory syncytial virus and COVID-19 infections continue to sweep across parts of the nation.
It proved itself superior to AZD1222 (ChAdOx1-S), the vaccine by Astrazeneca-Oxford, in terms of geometric mean titer for neutralization antibodies.
The U.S. FDA greenlit a new indication for Gilead Sciences’ drug Biktarvy for pediatric patients with HIV who are virologically suppressed or new to antiretroviral therapy.
Vertex Pharmaceuticals announced positive Day 90 data from the first patient in its Phase I/II study of VX-880 in type 1 diabetes.
Phathom announced positive results from its Phase III trial, PHALCON-EE, comparing vonoprazan against lansoprazole in patients with moderate to severe erosive esophagitis.
The concern relates to the risk of two rare heart inflammation conditions, myocarditis and pericarditis, that have been linked to the Pfizer and Moderna mRNA vaccines.
Omeros Corporation shares were down in premarket trading after the company received a CRL for its experimental hematopoietic stem cell transplant-associated thrombotic microangiopathy treatment.
Biogen announced topline results from the Phase III VALOR trial of tofersen for superoxide dismutase 1 amyotrophic lateral sclerosis.
The FDA reviewed Tecentriq under Project Orbis, allowing the simultaneous submission and review of potential oncology treatments to international regulatory bodies.
Cartesian’s Descartes-08 is a new chimeric antigen receptor (CAR) - T cell therapy that strives to target the myasthenia gravis disease at its source.
Biopharma companies recognized that developing a therapy is merely the beginning of what is needed to connect patients with sickle cell disease to next-level therapies.
The U.S. Food and Drug Administration has a few PDUFA dates on its calendar for this week. Here’s a look.