FDA APPROVALS

FDA approves first drug for breast cancer with BRCA geneFDA approved the first drug to treat certain patients with metastatic breast cancer who have a “BRCA” gene mutation.
Top 3 new drug approvalsHere are 3 of the top new drug approvals in late December and early January.
New treatment for advanced kidney cancer approved
New treatment for advanced kidney cancer approvedFDA expanded the indication on cabozantinib (Cabometyx, Exelixis) to treat patients with advanced renal cell carcinoma (RCC).
Pfizer won't launch its second Remicade biosimilar in U.S.
FDA okays short-acting follow-on insulin for diabetes
FDA okays short-acting follow-on insulin for diabetesFDA okays the first short-acting insulin approved as a “follow-on” product.
FDA okays new diabetes, asthma drugsFDA recently approved a new diabetes medication, as well as a drug to treat severe asthma.
FDA approves first once-monthly injection for opioid abuseSoon 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).
FDA approves breakthrough cancer gene test
FDA approves breakthrough cancer gene testFDA approved a new cancer biomarker test that can detect genetic mutations in 324 genes and 2 genomic signatures in tumors.
FDA clears first opioid withdrawal deviceFDA granted a new indication to a device that can help reduce the symptoms of withdrawal from the prescription pain drugs.
FDA approves first pill that can be tracked when ingestedFDA approved the first drug in the United States that has a digital ingestion tracking system, which records when the medication was taken.

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