Even though another biosimilar to infliximab (Remicade) was approved by FDA in mid-December, it likely won’t be marketed in the United States.
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.
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 granted a new indication to a device that can help reduce the symptoms of withdrawal from the prescription pain drugs.
FDA approved the first drug in the United States that has a digital ingestion tracking system, which records when the medication was taken.
FDA approved the first test that detects the Zika virus in blood donations and living organ donations.