We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
With the FDA stepping up scrutiny of data integrity during facility inspections, drugmakers must be ready to answer tough questions about their electronic record system, an inspections expert said. Read More
Nothing is stopping Sandoz from launching the first U.S. biosimilar, now that a federal judge has denied Amgen’s bid for an injunction blocking the alternate version of its blockbuster chemotherapy product Neupogen. Read More
The FDA and Department of Justice are pursuing prosecutions of several international drugmakers for serious manufacturing quality violations, underscoring the agency’s increasing tendency to treat quality violations as fraud. Read More
Hundreds of children as young as two years old will now be able to get Vertex Pharmaceuticals’ game-changing cystic fibrosis treatment, following FDA approval Thursday. Read More
Janssen’s blockbuster Xarelto is the target of another liability lawsuit, this time by 12 plaintiffs in California federal court who claim the blood thinner caused gastrointestinal bleeding. Read More
Advocacy group Public Citizen is urging the FDA to pull oral forms of the antifungal drug ketoconazole from U.S. shelves due to serious health risks. Read More
The Indian government is planning to relaunch a program that would sell hundreds of quality generic drugs at low cost under its own label, Jan Aushadhi. Read More
The drug pricing authority in India published a compilation of the price caps for 509 drugs, effective this past Jan. 31, to give drugmakers a single source of pricing information. Read More