Food and Drug Administration (FDA)

NEWS
Ztalmy is Marinus’ oral suspension medication for patients ages two years and older who experience seizures linked with cyclin-dependent kinase-like 5 deficiency disorder.
BMS achieved a monumental milestone when the U.S. Food and Drug Administration approved Opdualag (nivolumab and relatlimab-rmbw) for the treatment of melanoma.
Merck announced that its proposed treatment Keytruda for non-small cell lung cancer delivered positive results from its Phase III trial.
Although there is talk of a fourth shot of the COVID-19 vaccine the data so far suggest the benefits may be modest. Continue reading for details and more COVID-19 news.
FDA
Lamassu Bio, Inc. is setting its sights on the unmet needs of the pharmaceutical industry as it announces a new venture to develop therapeutics for cancer.
Eiger BioPharmaceuticals announced that its COVID-19 therapeutic, Peginterferon Lambda reduced the risk of hospitalization and emergency room visits by 50%.
This is the first approval for the drug in gastroenterology and was based on data from three Phase III trials.
The U.S. Court of Appeals for the Federal Circuit denied Biogen a second look into the patent dispute filed against Mylan for Biogen’s Multiple Sclerosis (MS) drug, Tecfidera.
Now that Omicron is becoming less common, its sister variant, BA.2, seems to be surging worldwide and in the U.S. For that and more, continue reading.
JOBS
IN THE PRESS