The Food and Drug Administration has approved a new injectable diabetes drug from Eli Lilly and Co. for adults with the most common form of the disease. The agency on Thursday cleared the drug, Trulicity, as a weekly injection to improve blood sugar control in patients with type 2 diabetes.
Baxter International Inc. announced today it is voluntarily recalling one lot of Potassium...
Movantik, or naloxegol, is approved for adults who have chronic pain that is not caused by...
A nonpartisan congressional agency is raising new questions about compliance with a key...
Potential complications await consumers as President Barack Obama's health care law approaches its second open enrollment season, just two months away. Don't expect a repeat of last year's website meltdown, but the new sign-up period could expose underlying problems with the law itself that are less easily fixed than a computer system.
Baxter International and Halozyme Therapeutics announced that the FDA approved Baxter’s subcutaneous treatment for adult patients with primary immunodeficiency (PI), HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase].
The powerful chemical industry is putting its lobbying muscle behind legislation that would establish standards for chemicals used in products from household goods to cellphones and plastic water bottles — but also make it tougher for states to enact their own regulations.
Hospira is initiating a voluntary nationwide user-level recall of one lot of Heparin Sodium, 1,000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.9% Sodium Chloride Injection, 500 mL, NDC 0409-7620-03 Lot 41-046-JT with expiration date of 01NOV 2015. This action is due to one confirmed customer report of particulate in a single unit.
The drug is approved for use by people who have a body mass index of 30 or higher, which is the level at which people are considered to be obese. It is also approved for use by people with a BMI of 27 or higher who also have a weight-related medical condition such as diabetes.
European regulators have approved a long-lasting insulin from Eli Lilly and Co. and German drugmaker Boehringer Ingelheim that is the subject of patent infringement litigation with French rival Sanofi.
Attorney General Eric Holder is announcing a new nationwide 'take-back' program to help combat prescription drug abuse, a problem he calls an "urgent and growing threat."
Sanofi Pasteur, the vaccines division of Sanofi, announced that the FDA has approved the use of Menactra [Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine] for booster vaccination against meningococcal disease in persons 15 years through 55 years of age.
Pharmacy Creations has voluntarily recalled four product lots (see below) following testing results conducted by Front Range, Inc., its former independent testing laboratory, that indicated that the product lots may have the potential of not being sterile.
Silvergate Pharmaceuticals today announced that the FDA approved Epaned (enalapril maleate Powder for Oral Solution) for the treatment of symptomatic heart failure and the treatment of asymptomatic left ventricular dysfunctio.
The FDA approved the company's ferric citrate drug to treat patients on dialysis with hyperphosphatemia, or elevated levels of phosphates, which can increase the risk of heart disease, bone density problems and death. Keryx estimates that between 350,000 and 375,000 U.S. dialysis patients take medication to control their phosphate levels, representing a total market of $1.2B.
The U.S. Food and Drug Administration has granted accelerated approval to Keytruda (pembrolizumab) for treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs.
Regeneca Worldwide a division of VivaCeuticals, Inc. Las Vegas, NV is expanding the voluntary nationwide recall of its RegeneSlim appetite control dietary supplement to include lot #823230415, lot #EX0616r 15813, Lot # EX0616R15814 and Lot #11414re5516 because FDA analysis confirmed the presence of DMAA.
Years before Burger King sized up a Canadian headquarters in a hunt for lower taxes, Republican U.S. Senate candidate Mike McFadden's investment firm was involved in a merger that moved an American pharmaceutical company to Ireland and significantly dropped its tax rate.
Pfizer and Protalix BioTherapeutics announced that the FDA approved ELELYSO™ for injection for pediatric patients. ELELYSO is therefore now indicated for long-term enzyme replacement therapy (ERT) for adult and pediatric patients with a confirmed diagnosis of Type 1 Gaucher disease.
Bristol-Myers Squibb Company today announced that the European Commission has approved Daklinza (daclatasvir) for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of chronic hepatitis C virus (HCV) infection in adults.
Ligand Pharmaceuticals Incorporated announced that its partner GlaxoSmithKline has received approval of a supplemental New Drug Application (sNDA) for the once-daily use of Promacta®/Revolade™ (eltrombopag) in patients with severe aplastic anemia (SAA) who have had an insufficient response to immunosuppressive therapy (IST).
Fresenius Kabi announced today it has received approval from the U.S. Food and Drug Administration for Kabiven ® and Perikabiven ®, parenteral nutrition (PN) products in a three-chamber bag – the only container of its kind available in the United States.
Iroko Pharmaceuticals, LLC, announced today the United States Food and Drug Administration (FDA) has approved ZORVOLEX (diclofenac) capsules, a nonsteroidal anti-inflammatory drug (NSAID), for the management of osteoarthritis pain.
Amgen Recalls Aranesp Prefilled Syringes in Several Countries Outside of the U.S. Due to the Presence of Visible ParticulatesAugust 14, 2014 9:05 am | News | Comments
Amgen initiated a voluntary recall on June 26, 2014 for nine packaged lots of Aranesp (darbepoetin alfa) (500 mcg) prefilled syringes from non-U.S. distributors, wholesalers and a number of hospital pharmacies due to the potential presence of cellulose and/or polyester particles observed in a small number of syringes during a routine quality examination.
Merck & Co. has won federal approval for a new type of sleeping pill designed to help people with insomnia stay asleep. The tablet, Belsomra, works by temporarily blocking chemicals known as orexins that control the sleep cycle and can keep people awake at night.
The Food and Drug Administration said Tuesday that the approval of the XVIVO Perfusion System could lead to more successful transplants of lungs for people with cystic fibrosis and other deadly respiratory diseases.
The clock is ticking for hundreds of thousands of people who have unresolved issues affecting their coverage under the new health care law. The Obama administration said Tuesday that letters are going out to about 310,000 people whose citizenship or immigration details don't match what the government has on file.
The Cologuard test from Exact Sciences detects irregular mutations in stool samples that can be an early warning sign of cancer. Patients who test positive for the mutations should undergo a colonoscopy to confirm the results.
INVOKAMETT provides the clinical attributes of INVOKANA (canagliflozin), the first sodium glucose co-transporter 2 (SGLT2) inhibitor available in the United States, together with metformin, which is commonly prescribed early in the treatment of type 2 diabetes.
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