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The FDA has approved GlaxoSmithKline and Genmab’s Arzerra and Leukeran as a first-line combination treatment for the most common form of blood and bone marrow cancer. Read More
Impax said Friday it has refiled an NDA for its Parkinson’s disease drug Rytary after implementing quality systems improvements at the plant where the drug was slated to be made. Read More
The EMA is tightening stability testing requirements for drugmakers submitting applications for significant post-approval manufacturing changes that involve active substances. Read More
Indian authorities quietly suspended Ranbaxy’s Toansa facility from exporting active pharmaceutical ingredients to Europe late last month, signaling the country’s new, tougher approach to manufacturing quality violations. Read More
GPhA and its European counterpart want the FDA and European Medicines Agency to create uniform approval pathways for biosimilars and generics, saying standardization would lower drug costs and eliminate the need for duplicate clinical trials for the same product. Read More
The FDA has banned imports from active pharmaceutical ingredient maker Canton Laboratories, the fourth Indian drugmaker in a month to be put on import alert for poor quality. Read More
Australia’s Therapeutic Goods Administration (TGA) has set a September deadline for companies to adopt a common technical document format for OTC regulatory submissions. Read More
U.S. and EU regulators have both determined that Boehringer Ingelheim’s volasertib for acute myeloid leukemia is an orphan drug, the German drugmaker said Thursday. Read More
The European Medicines Agency will publish a guideline next year specifying how drugmakers will have to code and share medication errors with regulators. Read More
The European Medicines Agency is urging healthcare providers to inspect vials of the cancer drug Herceptin for signs of tampering following reports that some vials of the drug were stolen in Italy, tampered with and reintroduced into the supply chain. Read More