INC Research to perform FDA due diligence audit of regulatory documents for Provectus
The audit will be conducted in two phases, both of which are expected to be completed by early November 2014. In the first phase, INC Research Quality and
AstraZeneca has received approval from the Emirates Drug Establishment (EDE) in the UAE for Baxfendy, a medicine using the active ingredient baxdrostat, for uncontrolled hypertension.
Triumeq is a once-daily single-pill regimen, which combines the integrase strand transfer inhibitor (INSTI) dolutegravir with the nucleoside reverse transcriptase inhibitors (NRTIs) abacavir and lamivudine. ViiV Healthcare Canada
Opdivo (nivolumab) is BMS’s investigational PD-1 immune checkpoint inhibitor, while Imbruvica (ibrutinib) is an oral Bruton’s tyrosine kinase (BTK) inhibitor co-developed and co-marketed by Pharmacyclics and Janssen. The
"We are elated following the FDA’s approval of our IND application for MT-3724 and are eager to begin the next steps of our clinical journey with Veristat. Veristat
If granted, the FDA orphan drug designation will provide the company special development and commercial assistance, including a seven year period of marketing exclusivity. In September, the company