FDA approved Tresiba (insulin degludec injection, Novo Nordisk) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection, Novo Nordisk) for the treatment of diabetes mellitus.
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FDA has approved cariprazine (Vraylar, Allergan and Gedeon Richter Plc.) for the treatment of schizophrenia and bipolar I disorder in adults.
AstraZeneca recently released positive new data on its experimental non-small cell lung cancer (NSCLC) drug, AZD9291 (osimertinib)
Proteus Digital Health along with the pharmaceutical company, Otsuka, has submitted the first Digital Medicine New Drug Application (NDA) for the combination tablet of Abilify (aripiprazole) embedded with a Proteus ingestible sensor.
Aspirin should be taken daily in low doses by certain people to not only prevent heart disease and stroke, but also colon cancer, according to new draft guidelines.
The latest specialty drug pricing debate centers around Daraprim for toxoplasmosis infections, the price of which skyrocketed 5,000% within a month.
The U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) and Regeneron Pharmaceuticals in Tarrytown, New York, are partnering to develop a novel Ebola virus treatment.
FDA announced new requirements for the monitoring, prescribing, and dispensing of clozapine, an atypical antipsychotic for treatment-resistant schizophrenia, due to the continued risk of severe neutropenia, which can be life-threatening.
While biosimilars’ savings will not reach the historically high level achieved for small-molecule generic drugs, the impact on the healthcare industry will still be significant, according to a new report.
Joint FDA advisory committees voted 23-1 against approving Purdue Pharma’s immediate release opioid painkiller Avridi last week.
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FDA has expanded approval for ticagrelor (Brilinta, AstraZeneca) to include long-term use in patients with a history of heart attack.
FDA approved aspirin extended release capsules (Durlaza, New Haven Pharmaceuticals, Inc.) for the prevention of stroke and acute cardiac events.
The FDA has strengthened its warning for the type 2 diabetes medicine canagliflozin (Invokana, Invokamet) related to the increased risk of bone fractures, and added new information about decreased bone mineral density.
Alynlam Pharmaceuticals and The Medicines Company reported positive initial results from their ongoing Phase 1 clinical trial with their injectable cholesterol-lowing drug, ALSN-PCSsc, at the ESC Congress 2015 held in London, August 29 – September 2.
Healthcare providers, celebrities, patients and others are helping to increase awareness of idiopathic pulmonary fibrosis (IPF) during the Pulmonary Fibrosis Foundation’s (PFF) Pulmonary Fibrosis Awareness Month.
Pre-exposure prophylaxis (PrEP) may prevent HIV infection, according to a study published in Clinical Infectious Diseases. It is one of the first and largest published evaluations of the use of PrEP to prevent HIV infection in a clinical practice setting.
FDA has approved rolapitant (Varubi, Tesaro) for the prevention of chemotherapy-induced nausea and vomiting.
Rituxan (rituximab) has a consistent safety profile through multiple courses over 11 years of observation, according to a new long-term study published in the online edition of The Journal of Rheumatology.
The first biosimilar drug approved by FDA in March was officially launched in the United States on September 3 – at a value compared to competing medications.
FDA warned this week that several leading drugs for type 2 diabetes may cause severe and disabling joint pain. FDA said that sitagliptin, saxagliptin, linagliptin, and alogliptin may cause joint pain, and added a new Warning and Precaution about this risk to the labels of all dipeptidyl peptidase-4 (DPP-4) inhibitors.
Pharmacies should be wary of potential drug name changes that could occur if FDA finalizes its new draft guidance on biosimilar naming, which proposes proper names for biosimilars.
FDA has approved empagliflozin and metformin hydrochloride (Synjardy, Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company) tablets for the treatment of adults with type 2 diabetes.
FDA has expanded approval of eltrombopag (Promacta, Novartis) to treat low blood platelet count in pediatric patients with chronic immune thrombocytopenic purpura.
Fortune describes the 5 fastest-growing US pharmaceutical manufacturers.
4 things formulary managers can do to save lives and resources.
FDA’s approval of the first 3D-printed pill – Spritam to control epileptic seizures – will have a major impact on the medical and pharmaceutical community as a whole.
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