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FDA reviewers raise issues with Capricor Therapeutics resubmitted deramiocel for treating cardiomyopathy in male patients with Duc...[ Price : $8.95]
FDA encourages cancer clinical trial sponsors to adopt more flexible eligibility criteria related to washout periods and concomita...[ Price : $8.95]
A final FDA guidance urges sponsors of cancer clinical trials to broaden laboratory value-based eligibility criteria to reduce unn...[ Price : $8.95]
FDA announces an 8/6 educational Webinar to provide stakeholders with additional information about its proposed Expedited Investig...[ Price : $8.95]
An FDA advisory committee 7/23 voted to recommend allowing several controversial peptides to be considered for inclusion on the ag...[ Price : $8.95]
Amgen files new scientific data and analyses in its bid to prevent FDA withdrawal of Tavneos (avacopan), arguing that the treatmen...[ Price : $8.95]
FDA issues a Complete Response Letter to Apiject Systems Corp., declining to approve the company's NDA for a glycopyrrolate soluti...[ Price : $8.95]
FDA issues an early alert warning about a potentially high-risk issue involving certain lots of Boston Scientific's ENROUTE Transc...