FDA Approvals

FDA approves breakthrough drug for HIV patients with dwindling optionsA new FDA-approved drug offers new hope for patients with multidrug-resistant HIV-1 infection.
3 new FDA drug approvalsFDA recently approved 3 major drugs to treat lung cancer, prostate cancer, and cystic fibrosis. Here are the top 3 new drug approvals.
Combo UTI drug can now treat costly pneumoniasFDA approved Allergan's supplemental New Drug Application (sNDA) to expand the approved use of ceftazidime and avibactam (Avycaz) to include 2 types of pneumonia.
Radioactive drug for digestive cancer snags FDA approvalFDA approved a new drug to treat a type of cancer that affects the pancreas or gastrointestinal tract.
Blindness gene therapy price tag stirs controversyA patient advocacy group is criticizing the hefty price tag of a new treatment for blindness.
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.