The U.S. drug regulator asked Pfizer, Eli Lilly and AbbVie to include information about the risks of serious conditions and death from the use of their drugs that belong to a class of treatments known as JAK inhibitors.
The U.S. Food and Drug Administration warned health care personnel not to make any changes to the dosing of Covid-19 vaccines and that doing so would place the public health at risk and undermine “the historic vaccination effort to protect the population.”
U.S. prosecutors are pursuing possible penalties of nearly $13 billion to resolve investigations of OxyContin maker Purdue Pharma after uncovering evidence of criminal and civil misconduct stemming from the company’s alleged role in fueling the nation’s opioid crisis, people familiar with the matter said.
Eli Lilly is moving quickly to get the newly approved precision oncology treatment Retevmo for certain lung and thyroid cancers into the hands of patients.
The FDA warned health-care providers to stick to dosing recommendations for Intercept Pharma’s liver disease medicine Ocaliva after 19 patient deaths were reported.
The U.S. Food and Drug Administration on Thursday approved Merrimack Pharmaceutical Inc’s pancreatic cancer drug, Onivyde, with a severe safety warning. The company’s shares fell as much as 28 percent to a 13-month low of $7.27 in afternoon trade before halving the losses. Onivyde, in combination with chemotherapy treatments 5-fluorouracil and leucovorin, aims to treat […]
(Reuters Health) – According to a reanalysis of the original data from a 2001 study of paroxetine (Paxil) for teens with major depression, the drug was not effective and led to serious side effects, which is not how the results were presented 14 years ago. “There have been warnings about paroxetine for a long time,” […]
RIDGEFIELD, Conn. and INDIANAPOLIS, Aug. 27, 2015 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has approved Synjardy® (empagliflozin and metformin hydrochloride) tablets, from Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company (NYSE: LLY), for the treatment of adults with type 2 diabetes (T2D). SYNJARDY is the third product containing empagliflozin to […]
EUGENE, Ore., July 10, 2015 /PRNewswire/ — The U.S. Food and Drug Administration announced that it is strengthening an existing label warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of heart attack or stroke. The new policy pertains to both over-the-counter and prescription NSAID labels. The FDA reached its decision to strengthen NSAID warning […]
The Food and Drug Administration strengthened its safety warnings about heart-attack and stroke risks linked to a class of common pain relievers that includes medicines such as Celebrex, Advil, Motrin IB and Aleve. The FDA said new data have caused it to conclude that the medicines—called NSAIDs, for nonsteroidal anti-inflammatory drugs—definitely cause an increased risk […]