FDA

FDA takes tough stance on kids’ opioid cold medsFDA is taking its toughest stance yet on opioid-containing cough and cold medications for children.
FDA approves first drug for breast cancer with BRCA geneFDA approved the first drug to treat certain patients with metastatic breast cancer who have a “BRCA” gene mutation.
Top 3 new drug approvalsHere are 3 of the top new drug approvals in late December and early January.
Top 5 pipeline drugs for 2018
Top 5 pipeline drugs for 2018New blockbuster drugs to treat various conditions are expected to be among the top drugs to hit the marketplace in 2018. Here are 5 of the top new drugs in the pipeline for 2018, according to analysts.
Pfizer won't launch its second Remicade biosimilar in U.S.
FDA okays short-acting follow-on insulin for diabetes
FDA okays short-acting follow-on insulin for diabetesFDA okays the first short-acting insulin approved as a “follow-on” product.
FDA clears first opioid withdrawal deviceFDA granted a new indication to a device that can help reduce the symptoms of withdrawal from the prescription pain drugs.
FDA advisors recommend 2 opioid use disorder drugsTwo opioid use disorder drugs have been recommended for approval by FDA committees.
FDA okays unique injectable for type 2 diabeticsFDA approved a new once-weekly, single-dose autoinjector device to improve glycemic control in adults with type 2 diabetes.
FDA alters stance on opioid addiction drugs
FDA alters stance on opioid addiction drugsFDA is advising that these 2 opioid addiction medications should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system.