MyoKardia (NASDAQ:MYOK), a leading precision cardiovascular medicine company, reported good data during 2015-16 on its drug, mavacamten, to treat hypertrophic cardiomyopathy (HCM), a condition that reduces the rate of heart contractions because of the thickening of surrounding heart muscles. Mavacamten, […]
Dynavax’s (NASDAQ:DVAX) BLA application for its Hepatitis B vaccine first received a complete response letter from the FDA in 2013 and then experienced further regulatory delays between 2015-2016. Some of the FDA requests involved the vaccine’s overall immunogenicity data, while […]