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Baxter is recalling two lots of Clinimix and one lot of Clinimix E premixed sterile parenteral nutrition products over complaints of particulate matter. Read More
China’s Food and Drug Administration (CFDA) is renewing its push to have all manufacturers of blood products, vaccines and sterile injectables obtain a revised good manufacturing practices (GMP) certificate. Read More
Roche subsidiary Genentech received a Form 483 from the FDA after an inspection found parts of the processing area for making active pharmaceutical ingredients (APIs) was covered with what resembled rust. Read More
FDA Chief Scientist Jesse Goodman is leaving for Georgetown University and the D.C. Veterans Administration Hospital to serve as a professor and to practice medicine, FDA Commissioner Margaret Hamburg said Thursday. Read More
Highlighting a growing dispute in the pharmaceutical industry, Johnson & Johnson is arguing that biosimilars should have international non-proprietary names (INN) that are similar to, but distinguishable from, reference products. Read More
Novartis’ valsartan woes escalated Thursday as Japan followed the U.S. in filing a legal complaint against the Swiss drugmaker over its marketing practices for the blood pressure drug. Read More
Drugmakers should evaluate a product’s UV-visible absorption spectrum before starting clinical development, the ICH says in a new guideline that will standardize photosafety testing standards across the EU, Japan and U.S. Read More
The European Medicines Agency is encouraging drugmakers looking to apply novel drug development tools to seek the EMA’s blessing first and get qualification or prospective advice. Read More
Less than a month after AstraZeneca said it was buying out Bristol-Myers Squibb’s part of its diabetes pipeline partnership, the FDA Wednesday approved their type 2 diabetes drug Farxiga. Read More