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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
Elite Laboratories has been given a warning letter due to a failure to develop adequate written procedures, particularly for adverse drug experiences (ADEs). Read More
An FDA inspection found microbiological contamination of drugs purporting to be sterile at a Bausch & Lomb manufacturing facility in Florida, according to a Form 483 handed to the company. Read More
Cheng Fong Chemical received a warning letter from the FDA for dirty equipment, poorly maintained facilities and improper investigations into possibly tainted batches of active pharmaceutical ingredients. Read More