CTP-656 is an investigational cystic fibrosis transmembrane conductance regulator (CFTR) potentiator that has the potential to be used as part of future once-daily combination regimens of CFTR modulators
This ground-breaking IND paves the way for bringing a new precision immunotherapy for the treatment of cancers into the clinic this year. ADXS-NEO employs Advaxis’ proprietary Listeria monocytogenes
Ongoing and future trials using the oral formulation of SCY-078 are unaffected by this regulatory action. A meeting with the FDA to discuss these data and to agree
The trial met its primary endpoint of demonstrating a clinically meaningful and a statistically significant increase in overall survival (“OS”), in the intention-to-treat (ITT) population of patients treated
Ocaliva has been conditionally approved in the European Union for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate
Ataluren was generally well tolerated and ACT CF confirmed a favorable safety profile for ataluren, which has now been used by more than 1,000 patients across multiple indications.
The NDA was granted Priority Review and has been given a Prescription Drug User Fee Act (PDUFA) action date of Aug. 30, 2017. Celgene completed the NDA submission
APS is a disorder of the immune system, where abnormal antibodies, called antiphospholipid antibodies (aPL) are produced. These bind to beta-2-glycoprotein (beta-2-GPI) in the blood and increase the
“We are seeing a wave of new legislation being introduced as governments all over the world seek to educate consumers via product packaging,” said Philippe Adam, Vice President
The partnership will utilize Affinivax’s proprietary vaccine technology platform – Multiple Antigen Presenting System (MAPS) – to advance a novel MAPS vaccine targeted to prevent and reduce the
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