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CBER recently used a virtual town hall to urge developers of cell and gene therapies to take advantage of early engagements with t...[ Price : $8.95]
An FDA final guidance encourages sponsors of oncology clinical trials to broaden eligibility criteria by including more patients w...[ Price : $8.95]
FDA reviewers raise issues with Capricor Therapeutics resubmitted deramiocel for treating cardiomyopathy in male patients with Duc...[ 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...[ 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]
FDA cites Bausch + Lomb for GMP deficiencies following a 3/12-20 inspection of the company's sterile drug manufacturing facility i...