The FDA cannot accept any new funding during the shutdown, now in its 28th day, forcing the agency to stretch its remaining money to last only about five more weeks.
CNBC's Kate Rogers reports on how the government shutdown, now entering its 28th day, is affecting small businesses and entrepreneurs all across the country.
Jan 17- Independent experts on an advisory panel to the U.S. Food and Drug Administration were divided over whether to recommend approval of a treatment for type 1 diabetes developed by Lexicon Pharmaceuticals Inc and France's Sanofi SA. At the panel meeting, patients who were part of the trials advocated the drug's effectiveness, but FDA staff flagged the risk...
The FDA's change clears the way for drugmakers to sell naloxone without a prescription. The life-saving treatment for opioids is also known as Narcan and Evzio.
Jan 16- An advisory panel to the U.S. Food and Drug Administration said on Wednesday that benefits of Amgen Inc's osteoporosis treatment for postmenopausal women at high risk for fracture outweighed its risks and overwhelmingly voted for the drug's approval. The panel, however, raised concerns of cardiovascular safety risks linked to the drug, which FDA staff...
The Food and Drug Administration said it will resume inspections of some of the riskiest foods such as cheeses, produce and infant formula as early as Tuesday.
In 2014, the price of one kind of insulin increased by nearly 50 percent, even though it had already been on the market for more than a decade.
You can store it next to your 7-pound bucket of Nutella and 40-pound bucket of honey.
The FDA has stopped a large portion of its safety inspections, as about 41 percent of the organization's 17,000 employees have been furloughed due to the federal government's shutdown.
Jan 9- Akorn Inc said on Wednesday it received a warning letter from the U.S. Food and Drug Administration following an inspection of the company's Decatur, Illinois manufacturing plant last year. The FDA said the company's response to its Form 483, which lists observations from the inspection in April and May, was inadequate. RBC Capital Markets analyst...
Jan 9- Akorn Inc said on Wednesday it received a warning letter from the U.S. Food and Drug Administration following an inspection of the company's Decatur, Illinois manufacturing plant last year. The FDA said the company's response to its Form 483, which lists observations from the inspection in April and May, was inadequate. The FDA has asked the company to...
Jan 9- Akorn Inc said on Wednesday it received a warning letter from the U.S. Food and Drug Administration following an inspection of the company's Decatur, Illinois manufacturing plant last year. Lake Forest, Illinois- based Akorn said it would respond to the FDA letter within 15 working days and expects to continue production at the plant.
FDA Commissioner Scott Gottlieb's keynote address Tuesday was delivered via video conference from Washington, D.C., to thousands of bankers and health executives, and his audio cut out just as he was making a key point on teen nicotine use.
Editas Medicine president and CEO Katrine Bosley discusses her company's gene editing technology and the future of medicine.
The campaign marks the start of a year Juul will need to spend proving to regulators its product is ending up where its supposed to — in the hands of adult smokers, not teenagers.
Wall Street's top cannabis analyst believes U.S. marijuana sales will jump to $80 billion and expects Canopy and Tilray to outperform.
The J.P. Morgan Healthcare Conference, the industry's biggest investor show, will bring more than 485 companies and 9,000 attendees to San Francisco.
Postpartum depression is considered the most common medical complication linked to childbirth, affecting one in nine women in the United States, according to the Centers for Disease Control and Prevention. The results come months after the U.S. Food and Drug Administration extended the review of the Massachusetts- based drug developer's lead drug Zulresso,...
CNBC's Eamon Javers reports on comments from President Trump on the stock market and immigration.
Jan 2- A U.S. unit of Indian generic drugmaker Aurobindo Pharma Ltd will recall 80 lots of medicines containing blood pressure drug valsartan that were found to have a probable cancer-causing impurity, according to the U.S. Food and Drug Administration. The impurity N-Nitrosodiethylamine was detected in quantities above the acceptable limit in certain...