Potential public health consquences prompts FDA to request removal of opioid pain medication.
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Adamis’ epinephrine injection promises to be a lower-cost alterative to EpiPen.
The first generic Truvada for treating and preventing HIV will be available, but when?
FDA approves Isentress at a higher dose for HIV-1 infected patients.
A new trial for AstraZeneca’s benralizumab shows promising results for severe asthma patients.
FDA has approved the first generic versions of Strattera (atomoxetine) for the treatment of attention deficit/hyperactivity disorder.
Lilly's galcanezumab proves successful in three phase 3 migraine studies. Here are the findings.
AstraZeneca voluntarily recalls professional samples of its antiplatelet agent. Here's what to do.
FDA approves ribociclib plus letrozole to treat a subset of advanced breast cancer patients.
The 13th edition EMD Serono Specialty Digest outlines top specialty drug management issues health plans face.
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A new study led by The University of California researchers and published in JAMA reveals surprising findings.
Based on new data from 2 large clinical trials, FDA is warning that these blockbuster type 2 diabetes medications can cause an increased risk of leg and foot amputations.
FDA expanded the use of ivacaftor (Kalydeco, Vertex Pharmaceuticals) to treat cystic fibrosis.
Scott Gottlieb, MD, was sworn in as the new FDA commissioner and ushers in a new era.
Soon after approving the same drug for metastatic Merkel cell carcinoma, FDA approved immuno-oncology avelumab (Bavencio) for locally advanced or metastatic urothelial carcinoma.
FDA recently approved the first new treatment for amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease, in more than 20 years.
Walmart, CVS Health, and a number of other healthcare organizations are supporting a new multi-million dollar consumer campaign to combat high prescription drug prices.
Late last week, FDA approved a new drug to treat acute myeloid leukemia (AML), the first treatment for Batten disease, and expanded the use of a current drug to treat liver cancer.
A new abuse-deterrent painkiller - oxycodone hydrochloride (RoxyBond, Inspirion Delivery Services) - will be available soon after receiving FDA approval.
In what is expected to produce hefty saving for rheumatoid arthritis patients and the healthcare system, FDA approved the second biosimilar to Remicade (Johnson & Johnson).
FDA said this week that it is restricting the use of codeine and tramadol medicines in children. The drug’s labels will now include a contraindication that codeine should not be used to treat pain or cough, and that tramadol should not be used to treat pain, in children younger than 12 years.
Citing safety concerns, FDA delayed approval of a new blockbuster drug to treat rheumatoid arthritis.
FDA approved supplemental applications for 2 primary hepatitis C medications to be used in children for the first time.
Two recent studies demonstrate that pirfenidone (Esbriet, Genentech) prolongs life expectancy by 2.47 years for IPF patients and that Esbriet and nintedanib (Ofev, Boehringer Ingelheim) reduce the decline in lung function.
FDA recently approved deutetrabenazine (Austedo, Teva Pharmaceuticals) to treat chorea associated with Huntington’s disease (HD). The medication is only the second product approved to treat HD, and is the first deuterated product approved by FDA.
While FDA just approved the first drug for primary progressive multiple sclerosis (PPMS), the drug’s price tag is controversial.
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