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.
The FDA expects to refine the review process and fee structure for biosimilar products in the next iteration of the Biosimilar User Fee Act to improve efficiency and resource availability. Read More
The French National Agency for Medicines and Health Products Safety (ANSM) released a statement alleging serious violations of good manufacturing practices at Nandu Chemicals Industries, an India-based API maker. Read More
The European Directorate for the Quality of Medicines and a number of foreign pharmaceutical authorities have agreed to improve information-sharing efforts and to strengthen collaboration. Read More
The FDA is revising the list of drug products that have been banned or removed from the market for safety or effectiveness reasons and so cannot be used in compounding. Read More
Two Phase III trials presented at the annual congress of the European Society for Medical Oncology showed advancements in first-line treatments for post-menopausal women with breast cancer. Read More
A federal court panel ruled that the Philadelphia law firm Sheller PC cannot challenge the FDA’s denial of a citizen petition, saying the firm lacks standing based on its failure to show a causal relationship between the agency’s actions and its financial burdens. Read More
Merck presented multiple studies over the weekend demonstrating positive results in metastatic non-small cell lung cancer with its Keytruda immunotherapy. Read More
Mylan will pay $465 million to settle claims that the company misclassified its epinephrine auto-injector EpiPen for the Medicaid Drug Rebate program, allowing it to pay lower reimbursement rate to states for almost a decade. Read More