Federal officials plan to review the safety and evidence behind alternative remedies like Zicam and Cold-Eeze, products that are protected by federal law, but not accepted by mainstream medicine.
The global pharmaceutical industry is pouring billions of dollars into developing treatments for...
Sanofi Pasteur, the vaccines division of Sanofi announced that FDAhas approved use of Quadracel...
Emergent BioSolutions has announced that the FDA has approved Anthrasil™ [Anthrax Immune...
The FDA has expanded the approved use for Eylea (aflibercept) injection to treat diabetic retinopathy in patients with diabetic macular edema.
The agency said its tracking of claims by cosmetics companies during recent years indicated a proliferation in drugs claims--defined by the FDA as "intended to treat or prevent disease, or change the body’s structure or functions"--on product packaging and in web advertising.
Government health advisers say a once-a-day respiratory inhaler from GlaxoSmithKline appears safe and effective for adults with asthma, but not for adolescents.
Vertex Pharmaceuticals has announced that the FDA approved KALYDECO® for use in children ages 2 to 5 with cystic fibrosis (CF) who have one of 10 mutations in the cystic fibrosis transmembrane conductance regulator ( CFTR) gene.
Actavis announced that the FDA has approved a lower therapeutic dose of VIIBRYD (vilazodone HCl) (20mg) to accompany the 40 mg daily therapeutic dose.
The Environmental Protection Agency and the Food and Drug Administration signed an agreement to share data relating to pesticides and toxic substances, the agencies announced Monday.
The company said Friday that the Food and Drug Administration has canceled a March 18 meeting to review sugammadex, which is designed to help patients "wake up" after surgical anesthesia.
Hospira Issues a Voluntary Nationwide Recall of One Lot of Lactated Ringer's Irrigation Due to Mold ContaminationMarch 13, 2015 8:40 am | News | Comments
Hospira is initiating a voluntary recall of one lot of Lactated Ringer's Irrigation, 3000mL (NDC 0409-7828-08, Lot 40-008-JT; Expiry 1APR2016) to the user level (both human and veterinary) due to a confirmed customer report of several dark, fibrous particulates floating within the solution of the primary container.
Actavis announced that the FDA has approved its supplemental new drug application (sNDA) for SAPHRIS (asenapine) as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients (ages 10 - 17).
The Made in the USA Foundation announced a complaint filed with the U.S. Food and Drug Administration that accused large drugstore chains of failing to provide the country of origin on prescription drug labels.
In a letter to House and Senate appropriations committee leadership, the groups instead sought additional funding for the U.S. Food and Drug Administration, a move they said would reflect food safety's status as "a top national priority."
A law that allows rural hospitals to bill Medicare for rehabilitation services for seniors at higher rates than nursing homes and other facilities has led to billions of dollars in extra government spending, federal investigators say.
Four members of Food and Drug Administration's tobacco advisory panel, including its chairman, have left after a federal judge ruled some of its members had conflicts of interest, the agency said.
Government health officials on Friday approved the first lower-cost copy of a biotech drug in the U.S., a long-awaited milestone that could save billions for insurers, doctors and patients.
In an encouraging development for consumers worried about antibiotics in their milk, a new Food and Drug Administration study showed little evidence of drug contamination after surveying almost 2,000 dairy farms.
The miserable flu season is winding down but not quite over yet, health officials said Wednesday, even as the government picked what it hoped would be a better vaccine recipe for next fall and winter.
FDA Approves Opdivo for the Treatment of Patients with Previously Treated Metastatic Squamous Non-Small Cell Lung CancerMarch 4, 2015 11:04 pm | News | Comments
Bristol-Myers Squibb Company has announced that the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection, for intravenous use, for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.
One of the nation's leading medical researchers joined the Food and Drug Administration on Monday, taking on the agency's No. 2 leadership job at a critical juncture for prescription drugs, medical devices and tobacco products.
Shares of Pacira Pharmaceuticals tumbled Monday after the company said regulators refused to grant a new marketing approval for its post-surgical pain drug Exparel.
Bipartisan Act would preserve FDA user fees from sequestration.
Federal prosecutors have indicted a New Jersey compounding pharmacy and top company officials on 37 charges, including wire fraud and violations of federal drug safety laws.
Studies of baby animals have long suggested that going under anesthesia can have some harmful effects on a developing brain. Now some scientists want to find out whether those same drugs may pose subtle risks for human babies and toddlers.
Legislation that would give terminally ill patients in Oklahoma access to experimental medications that are not yet on pharmacy shelves could restore a sense of dignity to those who are dying, the measure's author said Wednesday.
Federal health officials have approved a new antibiotic combination to treat several hard-to-treat infections. The drug contains two ingredients, cephalosporin and avibactam, designed to help fight antibiotic-resistant bacteria.
A recent report found that recalls of products overseen by the U.S. Food and Drug Administration fell during the final quarter of 2014 but the number of affected units increased.
- Page 1