FDA approved plecanatide (Trulance, Synergy Pharmaceuticals) for adults with chronic idiopathic constipation.
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FDA recently approved a long-acting opioid designed to deter abuse.
While President-elect Donald Trump recently said that the pharmaceutical industry is “getting away with murder” in terms of drug prices, the industry is trying to self-regulate before facing tighter rules from the incoming administration.
FDA recently expanded the use of antihemophilic factor (recombinant), pegylated (Adynovate, Shire plc) for hemophilia A patients under 12 years old.
Consumer health groups are praising Health and Human Services’ (HHS) new rule on the Medicaid 340B drug discount program, which sets a ceiling on drug prices.
FDA recently expanded approval of the G5 Mobile Continuous Glucose Monitoring System (Dexcom) to allow for replacement of fingerstick blood glucose (sugar) testing for diabetics.
While FDA approved far fewer new drugs in 2016 than 2015, the agency quickly approved novel and breakthrough therapies.
FDA recently approved rucaparib (Rubraca, Clovis Oncology) tablets to treat patients with deleterious BRCA mutation (germline and/or somatic)-associated advanced ovarian cancer, who have been treated with 2 or more chemotherapies.
FDA approved nusinersen (Spinraza, Biogen), the first drug to treat children and adults with spinal muscular atrophy (SMA), a rare and often fatal genetic disease affecting muscle strength and movement.
A new combination drug for type 2 diabetes will available in the US in the coming months.
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FDA issued two important drug warnings this week: one linking certain diabetes medications to bladder cancer and another about the use of general anesthetic and sedation drugs during pregnancy.
FDA recently approved bevacizumab (Avastin, Genentech) for patients with platinum-sensitive recurrent epithelial ovarian (psOC), fallopian tube or primary peritoneal cancer.
The US growth rate for spending on medicines is expected to fall in 2016 and beyond, according to new research.
FDA’s approval of a new indication for empagliflozin (Jardiance, Eli Lilly and Boehringer Ingelheim) could net the pharmaceutical manufacturers more than $1 billion.
Two new major studies on a biosimilar to trastuzumab (Herceptin, Genentech) to treat HER2-positive metastatic breast cancer and HER2-positive gastric cancer demonstrated equivalency.
Two new diabetes drugs, both long-acting injectable insulin products, were simultaneously approved by FDA.
A global phase 3 study of erenumab (Amgen and Novartis) showed that the drug was able to prevent migraines headaches.
After a successful phase 3 study, a breakthrough therapy to treat multi-drug resistant (MDR) HIV-1 is expected to launch in the United States in 2017.
After Gilead received FDA approval for a new drug for chronic hepatitis B virus (HBV), it said low-cost, generic versions would also soon be available. That is good news for Gilead, which has been targeted by Congressional representatives for the high cost of Sovaldi and Harvoni hepatitis C treatments.
FDA granted Breakthrough Therapy Designation to brentuximab vedotin (Adcetris, Seattle Genetics) to treat patients with the most common subtypes of lymphoma.
U.S. congressmen last week asked the Department of Justice and the Federal Trade Commission to investigate three insulin makers for price collusion-the latest in concerns over insulin prices.
In a big move for patients who take blood pressure medication on a regular basis, FDA last week approved the first generic versions of 4 drugs that contain the blood pressure-lowering medication olmesartan medoxomil (Benicar, Daiichi Sankyo).
Wide variation exists in practice-level statin prescribing for patients with diabetes, according to a new study.
New data presented at the 25th European Academy of Dermatology and Venereology (EADV) Congress in Vienna, Austria, this week shows that secukinumab (Cosentyx, Novartis) has long-lasting skin clearance in patients with moderate-to-severe plaque psoriasis.
Anthem Blue Cross recently launched a year-long diabetes prevention program to educate, treat and support its qualified California members who are at risk of developing type 2 diabetes.
As the healthcare profession continues to face challenges with antibiotic resistance, drugmakers are developing novel antibiotics that will be effective against some of the worst infections. One drugmaker submitted New Drug Applications (NDAs) for approval of IV and oral delafloxacin (Baxdela) to FDA.
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