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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...[ Price : $8.95]
Former FDA commissioner Rob Califf tells a cardiology technology convention that the U.S. needs to make significant changes to imp...[ Price : $8.95]
The Senate HELP Committee advances legislation sponsored by Sen. Rand Paul that he says will speed approval of biosimilar drugs by...[ Price : $8.95]
A just-posted Form FDA 483 cites SGS France Life Sciences following an 8/2025 inspection, identifying multiple deficiencies involv...