FDA issued a Drug Safety Communication on sildenafil (Revatio, Pfizer), following the observation in a long-term extension of a clinical trial in pediatric patients with pulmonary arterial hypertension of an increase in mortality with increasing Revatio dose.
Missouri study indicates LGBT discrimination and poorer health outcomes
Children with cystic fibrosis who are taking ivacaftor (Kalydeco) may be at potential risk for cataracts, according to an FDA notification.
FDA has approved tbo-filgrastim (Sicor Biotech UAB, a member of Teva Corporation), or XM02 filgrastim, the first new granulocyte colony-stimulating factor to be approved in the United States in more than 10 years to reduce the time certain patients receiving cancer chemotherapy experience severe neutropenia.
FDA has approved everolimus tablets for oral suspension (Afinitor Disperz, Novartis), a new pediatric dosage form of the anti-cancer drug everolimus (Afinitor, Novartis) used to treat a rare brain tumor called subependymal giant cell astrocytoma.
FDA has approved elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (Stribild, Gilead Sciences), a complete once-daily single tablet regimen for HIV-1 infection for treatment-naïve adults.
FDA has approved the supplemental New Drug Application for tapentadol extended-release tablets (Nucynta ER, Janssen), an oral analgesic taken twice daily, for the management of neuropathic pain associated with diabetic peripheral neuropathy in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
WellPoint has a history of major acquisitions, and the new CEO already has something on the to-do list.
FDA has approved Watson’s lidocaine topical patch 5%, the first generic version of Lidoderm (Endo) for the relief of pain associated with post-herpetic neuralgia.
FDA has approved buprenorphine and naloxone (Suboxone, Reckitt Benckiser Pharmaceuticals) sublingual film in the 4-mg and 12-mg strengths for the maintenance treatment of dependence on prescription opioid painkillers and heroin.
FDA approved Mylan Pharmaceutical's 15-mg, 30-mg, and 45-mg pioglitazone hydrochloride tablets, the first generic version of Actos (Takeda), along with diet and exercise to improve blood glucose control in adults with type 2 diabetes.
FDA has placed a partial clinical hold on Idenix Pharmaceuticals' nucleotide polymerase inhibitor under development for the treatment of hepatitis C virus.
FDA has issued a Drug Safety Communication concerning three children who died and one child who experienced a nonfatal but life-threatening case of respiratory depression after taking the pain-reliever codeine following tonsillectomy and/or adenoidectomy.
While employer-sponsored health benefits are not likely to disappear, changes that shift financial risk to employees are certain.
After five years at No. 1 in Surescripts’ Safe-Rx Awards, Massachusetts drops to No. 2 in the rankings of highest e-prescribing use in the nation during 2011.
Aurora Health Care has joined with Aetna to bring employers a new type of commercial health plan, the Aurora Accountable Care Network, which offers businesses a price guarantee
Legislators expect the bill to save $200 billion over the next 15 years.
FDA has approved the influenza vaccine formulation for 6 manufacturers for the 2012-2013 flu season.
FDA has approved vincristine sulfate liposome injection for the treatment of adult patients with Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia (ALL) who have had at least 2 relapses or whose disease has progressed following 2 or more anti-leukemia therapies
An ingestible sensor, formally referred to as the Ingestion Event Marker or IEM by Proteus Digital Health, that can report medication adherence and vital signs to physicians has been given the green light by FDA.
The passage of the FDA Safety and Innovation Act will support innovation, answer the current shortages, and even regulate mobile applications.
New molecular entity: FDA approved taliglucerase alfa (Elelyso, Pfizer), a recombinant active form of the glucocerebrosidase enzyme for long-term enzyme replacement therapy (ERT) for adults with type 1 Gaucher disease.
New formulation: FDA approved pancrelipase delayed-release capsules (Pertyze, Digestive Care, Inc.) for the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis or other conditions.
The Institute of Medicine reports that a number of issues are causing a number of barriers to successful HIV care in the United States.
Atrial fibrillation(AF) is the most common sustained cardiac arrhythmia and a potent risk factor for stroke. Here's a review of new oral anticoagulants for stroke prevention with AF.
The introduction of the immunomodulatory drugs and bortezomib, a proteasome inhibitor, has dramatically improved outcomes in patients with relapsed or refractory multiple myeloma.
Screening for hepatitis-C may soon become a routine screening for Baby Boomers.
A new study seems to indicate that adding cetuximab to the standard therapy for resected stage 3 colon cancer provides no additional benefits.
Recent FDA action (through July 2012) related to, morphine and oxycodone Dual Opioid platform, MoxDuo, QRxPharma, apixaban, Eliquis, Bristol-Myers Squibb, RG1068, Repligen, Multi-Stem, Athersys, Rivaroxaban, Xarelto, Janssen, Ocriplasmin intravitreal injection, ThromboGenics, Regorafenib, Bayer, Onyx Pharmaceuticals, Pregabalin, Lyrica, Lupin, Diclofenac sodium and misoprostol, Arthrotec, Watson, Next Choice One Dose, Plan B One-Step
The FDA recently announced a safety communication regarding the risk of seizures with MS who are starting dalfampridine.
