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FDA okays the first short-acting insulin approved as a “follow-on” product.
FDA recently approved a new diabetes medication, as well as a drug to treat severe asthma.
Soon after FDA approved a novel device to treat opioid use disorder, FDA approved the first and only once-monthly injectable buprenorphine formulation to treat moderate to severe opioid use disorder (OUD).
A new biosimilar to the cancer drug Herceptin, which raked in $2.5 billion in US sales last year, is expected to produce blockbuster sales in the US.
FDA approved a new cancer biomarker test that can detect genetic mutations in 324 genes and 2 genomic signatures in tumors.
FDA granted a new indication to a device that can help reduce the symptoms of withdrawal from the prescription pain drugs.
Because of the impact of Hurricanes Maria and Irma on Puerto Rico’s infrastructure and drug manufacturing, hospitals face an ongoing shortage of IV fluids manufactured there.
FDA approved the first drug in the United States that has a digital ingestion tracking system, which records when the medication was taken.
FDA warned 4 companies, which are claiming that their products containing cannabidiol, can treat or cure cancer.
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The first 2-dose hepatitis B vaccine, which was recently approved by FDA, is expected to be commercially available in early 2018.
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.
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.
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