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Since then, the agency has identified 35 cases of severely increased disability accompanied by multiple new lesions occurring two to 24 weeks after stopping treatment with Gilenya. Read More
The FDA said it instructed Novartis to place a new warning on labeling for its multiple sclerosis treatment Gilenya (fingolimod) and the agency issued a warning that abruptly ending treatment can severely exacerbate the disease. Read More
The unapproved products pose public health concerns for the users but also for the U.S. blood supply in the event of blood donations, the agency said. Read More
The review will assess the levels of NDMA in the valsartan drugs, the possible impact on patients that have been taking them and actions that can be taken to reduce or eliminate the impurity from future batches. Read More
Keytruda’s new indication is for treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing therapy and whose tumors express PD-L1 (Combined Positive Score ≥ 10), or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. Read More
Generic drug price competition may come at the cost of relaxed manufacturing standards, according to a study published in the Journal of Operations Management. Read More
Spotting shifting trends in opioid addiction and using a systematic approach to monitoring them is essential to protecting the public from the opioid crisis and intervening against it, top FDA officials said in the New England Journal of Medicine. Read More