A new position paper from noted thought leaders and the Association of Clinical Research Professionals provides the much-needed voice of the clinical trial professional.

After months of investigation, the U.S. Food and Drug Administration will not bring any penalties against Novartis over the data manipulation of the gene therapy Zolgensma, a multi-million dollar treatment for spinal muscular atrophy.

U.S. generic drugmaker Akorn is taking former suitor Fresenius to court after the German healthcare group canceled their $4.75 billion takeover agreement.

NEW YORK – A Chinese drug manufacturing facility run by Pfizer Inc. (PFE) is under scrutiny by the U.S. Food and Drug Administration (FDA) after regulators discovered the use of expired materials and a second set of quality and manufacturing records that did not match official documentation, Bloomberg reported this morning.   However, Pfizer said […]