[ 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...[ 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...[ Price : $8.95]
FDA publishes a strategy document on facilitating chemistry, manufacturing, and controls readiness for products in accelerated dev...