FDA has approved aripiprazole lauroxil (Aristada, Alkermes) extended-release injectable suspension for the treatment of adults with schizophrenia.
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There is new hope for patients with multiple sclerosis (MS) after positive data on Gilenya and the investigational drug ocrelizumab was presented at the Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Barcelona, Spain.
Soon after the FDA granted accelerated approval for Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC), it approved Opdivo (nivolumab) for an expanded use – to treat patients with advanced (metastatic) non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy.
First 2-drug therapy approved for advanced melanoma and four other recent approvals by FDA relating to new drugs and treatments.
The first biosimilar product was approved this spring. Pharmacists will want to familiarize themselves with this new class of therapies. Below are the five top things that a pharmacist should know about biosimilars.
Pulmonary fibrosis (PF) organizations and healthcare providers are lauding the update of the Official ATS/ERS/JRS/ALAT Clinical Practice Guideline: Treatment of Idiopathic Pulmonary Fibrosis, which was last updated in 2011.
FDA granted accelerated approval for Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC) whose disease has progressed after other treatments and with tumors that express a protein called PD-L1.
A novel influenza drug will advance in development, thanks to funding from the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR).
Pharmaceutical companies are charging up to 600 times what certain cancer drugs cost to make, and Americans are paying more than double the price charged in Europe for the tyrosine kinase inhibitors (TKIs).
The FDA’s accelerated drug reviews skip some important research methods – they typically do not use trials with active comparators or clinical outcome measures, according to two new studies.
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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.
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.
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.
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