Initiating antipsychotics may elevate a child’s risk not only for significant weight gain, but also for type 2 diabetes by nearly 50%, according to a study in JAMA Pediatrics. Moreover, among children who are also receiving antidepressants, the risk may double.
Actavis plc on Friday said it filed an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration (FDA) seeking approval to market Ambrisentan Tablets, a generic version of Gilead Sciences, Inc.'s Letairis®, a treatment for pulmonary arterial hypertension.
Patients diagnosed with deep vein thrombosis (DVT) and treated with rivaroxaban (Xarelto) were admitted to the hospital less frequently than those treated with the standard treatment of low-molecular-weight heparin (LMWH) and warfarin, according to real-world data presented at the Hospital Medicine 2015 Congress.
FDA actions in brief, priority review, breakthrough therapy designation, fast-track designations, orphan drug designations, first-time generic approvals
Coverage of specialty pharmaceuticals varies widely among health insurers, according to a new report from Atlantic Information Services in Washington, D.C.
Consumer advocacy group Public Citizen said this week that the Food and Drug Administration (FDA) must stop direct-to-consumer advertisements that market several “dangerous” diabetes medications for weight loss or blood pressure reduction.
Sarepta Therapeutics CEO Chris Garabedian resigned earlier this week, a move that may be linked to a dispute with the Food and Drug Administration (FDA) over the approval process for its new drug, according to The Wall Street Journal.
FDA has granted marketing clearance for Alere I Strep A Rapid Molecular Test (Alere). The Alere I molecular test initially received marketing clearance in June 2014 for the detection and differentiation of influenza A and B virus, and in January 2015, the test became the first-ever molecular test to receive a Clinical Laboratory Improvement Amendments (CLIA) waiver from the FDA.
Indiana Governor Mike Pence declared rural Scott County a public health disaster after it realized a spike in HIV cases linked to intravenous prescription drug abuse.
Roflumilast, a drug recently approved in the U.S. to treat severe chronic obstructive pulmonary disease (COPD), increases the production of a protein that causes inflammation – which possibly results in patients developing a tolerance to the drug after repeated use and renders it ineffective, according to a new study.
FDA has issued final guidance to assist industry in developing opioid drug products with potentially abuse-deterrent properties.FDA is encouraging manufacturers to develop abuse-deterrent drugs that work correctly when taken as prescribed, but, for example, may be formulated in such a way that deters misuse and abuse, including making it difficult to snort or inject the drug for a more intense high.
Aetna and Coventry Health Care of Florida are reclassifying certain HIV/AIDS medications labeled as specialty drugs to either generic or non-preferred brand drugs, according to Florida Insurance Commissioner Kevin M. McCarty.
FDA has approved a new administration option for ticagrelor (Brilinta, AstraZeneca) in acute coronary syndrome patients.
FDA has approved label update for abiraterone acetate (Zytiga, Janssen) in chemotherapy-naïve men with metastatic castration-resistant prostate cancer.
On March 31, the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) awarded approximately $12 million to BioCryst Pharmaceuticals of Durham, N.C., for the advanced development of a promising experimental drug for Ebola.
The cost of treating people infected with the hepatitis C virus (HCV) with newly approved therapies is likely to place a tremendous economic burden on the country’s healthcare system, according to a study published in the March 17 issue of the Annals of Internal Medicine.
Pharmaceutical manufacturer Novo Nordisk, based in Denmark, said it will re-submit its new insulin drug, Tresiba, to the Food and Drug Administration (FDA) for approval. The company could approval as early as this fall, which would signal a 2016 launch, according to Reuters.
A combination of medications effectively produced a sustained virologic response (SVR) in Hepatitis C virus (HCV) patients also infected with HIV, according to two new studies.
Discontinuing statin use in patients with late-stage cancer and other terminal illnesses may help improve patients’ quality of life without causing other adverse health effects, according to a study published in JAMA Internal Medicine.
Don’t use a kitchen spoon to give children liquid medications; instead use metric milliliter-only dosing, urges a statement, published online March 30 in Pediatrics.
Plaque psoriasis patients treated with secukinumab (Cosentyx) over ustekinumab (Stelara)-a widely used biologic-can achieve clearer skin, according to a late-breaking research session at the 73rd Annual Meeting of the American Academy of Dermatology (AAD), in San Francisco.
The Food and Drug Administration (FDA) is approving new drugs – especially those to treat cancer – at a near record pace this year.
FDA has approved use of Diphtheria and Tetanus Toxoids and Acellular Pertussis Absorbed and Inactivated Poliovirus; DTaP-IPV (Quadracel, Sanofi Pasteur, the vaccines division of Sanofi) vaccine for active immunization against diphtheria, tetanus, pertussis and poliomyelitis in children aged 4 through 6 years.
People who take more than 4 doses of medicine a day appear more likely to crush tablets or open capsules potentially reducing their effectiveness, according to a study published in the Journal of Pharmacy Practice and Research.
Health and Human Services (HHS) recently launched a widespread initiative – including increasing the use of naloxone to reverse opioid overdoses – aimed at reducing prescription opioid and heroin related overdose, death and dependence.
Pfizer and Eli Lilly and Company said they will resume Phase 3 clinical studies for tanezumab for chronic pain, after the Food and Drug Administration (FDA) lifted a partial hold on trials.
