As the FDA again reviews its guidance on disclosing prescription drug risk information, two New England Journal of Medicine articles are suspicious that new guidelines would change much for patients.
Hillary Clinton's plan to take away drugmakers' advertising tax deductions gets a resounding "no" from ad industry trade groups. While the ad executives aren't taking a stance on the rest of Clinton's drug-pricing plan, the advertising proposal gets a thumbs down.
The FDA is cracking down on Pathway Genomics for improperly marketing its liquid biopsy test, a couple of weeks after the company rolled out its product directly to consumers for the early detection of cancer.
Within weeks of getting a conditional nod to resume shipments from two of the company's manufacturing units in India, Canada's largest generics maker has recalled 117,644 bottles of cevimeline hydrochloride capsules in the U.S. that were made by the company's Indian arm, Apotex Research, the Business Standard newspaper reports.
The research arm of Sun Pharmaceutical Industries has seen its license for epilepsy drug Elepsia XR revoked by the U.S. FDA because of manufacturing violations at its production site, dealing a blow to its aims of moving beyond generics.
Two years after the FDA's shock rejection of Novo Nordisk's next-generation insulin, the Danish drugmaker has convinced U.S. regulators to change their tune, setting the stage for a market duel with Sanofi.
In an effort aimed at encouraging earlier diagnosis and even potentially prevention for Type 1 diabetes, the JDRF and the American Diabetes Association have published a new evaluation of the presymptomatic staging of Type 1 diabetes.
The European Medicines Agency is moving toward approving a trio of novel medicines from Roche, Boehringer Ingelheim and Gilead Sciences, handing down positive recommendations for each.
Novartis has predicted that its launch of newly FDA-approved heart failure med Entresto would be its "most exciting" ever. And now, it's one step closer to bringing that excitement to Europe.
Breast implant company Sientra saw its valuation cut in half on news that its contract manufacturer Silimed has had its CE mark suspended by the U.K. Department of Health. The move came after German regulators conducted an inspection of a Brazilian manufacturing plant--and regulators found that "the surfaces of some implants were contaminated with particles."