The first 2-dose hepatitis B vaccine, which was recently approved by FDA, is expected to be commercially available in early 2018.
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FDA warns that this compounded eye drug could lead to a disease that causes blindness.
More education is needed for diabetic patients after a patient died from incorrectly using an insulin pen, according to a new warning from the Institute for Safe Medication Practices.
If it is approved by FDA, an investigational drug to improve glycemic control in patients with type 2 diabetes will likely be a strong competitor to Eli Lilly’s dulaglutide (Trulicity).
FDA approved the herpes zoster vaccine (Shingrix, GlaxoSmithKline) to treat shingles in adults aged 50 years and older.
Soon after President Donald Trump declared the opioid abuse crisis a “public health emergency," shareholder activist groups said they aim to hold drug manufacturers and distributors liable for their part in the crisis.
Two opioid use disorder drugs have been recommended for approval by FDA committees.
FDA approved a new once-weekly, single-dose autoinjector device to improve glycemic control in adults with type 2 diabetes.
FDA Commissioner Scott Gottlieb, MD, said that the United States is likely to see shortages on certain drugs because after Hurricanes Irma and Maria knocked out power to the islands.
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FDA approved a new treatment for certain breast cancer patients who are not responding to treatment.
FDA approved the first continuous glucose monitoring system that allows for diabetes treatment decisions without requiring a fingerstick.
Pharma maker pleads guilty that one of its major drugs was misbranded in a federal court case brought by FDA and the US Department of Justice.
FDA approved the first generic version of oseltamivir phosphate (Tamiflu, Roche) for oral suspension to treat influenza A and B, plus 2 other noteworthy therapies.
FDA is advising that these 2 opioid addiction medications should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system.
While FDA has approved a handful of biosimilar drugs, the agency just approved the first biosimilar that treats a variety of types of cancer.
FDA warned about an injunction or seizure if Meridian Medical Technologies, a division of Pfizer, does not correct its problems with the EpiPen (epinephrine auto-injector).
An increased risk of deaths for patients in clinical trials receiving this cancer drug and two other drugs led FDA to stop the clinical trials.
A top-selling diabetes drug has gained a cardiovascular indication from FDA.
New biosimilars may harm the sales of this autoimmune blockbuster.
FDA approved a targeted new drug to treat adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
An FDA committee will review prescription opioid products containing hydrocodone or codeine to treat coughs in children.
Pharmacy and medical organizations lauded a new class action lawsuit against CVS Health and Walgreens, alleging the two pharmacy chains colluded with pharmacy benefit managers (PBMs) to drive up the cost of generic drugs.
FDA warned consumers and health care professionals not to use a certain brand of drugs and dietary supplements that are contaminated.
The Drug Enforcement Administration wants to slash the production of opioid painkillers by 20% in 2018.
FDA approved the first treatment for patients with a certain type of acute myeloid leukemia, as well as 2 new drugs to treat hepatitis C.
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