The U.S. health regulator added the FDA’s strictest warning to the labels of drugs from Pfizer, Eli Lilly and AbbVie belonging to a class of anti-inflammatory treatments called JAK inhibitors, citing risk of serious health issues and death in patients 50 and over, the drugmakers said on December 3.
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.
FDA Approves Eli Lilly’s Precision Oncology Treatment for Certain Lung and Thyroid CancersAccelerated Approval, Approvals, FDA, FDA/Regulatory, Metastatic Rearranged During Transfection (RET) Fusion-Positive Non-Small Cell Lung Cancer (NSCLC), New Drug Approvals, Precision Oncology, Product Launches, RET Kinase Inhibitors, Safety Warnings, Specialty Pharmacies, Tumors
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.
FDA clears Merrimack’s pancreatic cancer drug with warningAnalysts, Approvals, Breast Cancer, Clinical Trials, FDA/Regulatory, Forecasts, Health, Launches, Launches, Licensing, Licensing, New Drug Approvals, Pancreatic Cancer, Pediatric Sarcoma, Pricing, R&D, Safety Warnings, Shares, Shares, Studies, Therapeutics
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 […]
(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 […]
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) […]
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 […]