FDA Alerts
Uptravi Approved for Pulmonary Arterial Hypertension (PAH)
The U.S. Food and Drug Administration today approved Uptravi (selexipag) tablets to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive, and debilitating rare lung disease that can lead to death or the need for transplantation.
First Flu Vaccine with Adjuvant Approved
The U.S. Food and Drug Administration today approved Fluad, the first seasonal influenza vaccine containing an adjuvant.
FDA Approves Rx for Rare Lung Disease
The U.S. Food and Drug Administration today approved Rapamune (sirolimus), to treat lymphangioleiomyomatosis (LAM), a rare, progressive lung disease that primarily affects women of childbearing age. This is the first drug approved to treat the disease.
FDA Approves First Adjuvanted Vaccine for Prevention of Bird Flu
The U.S. Food and Drug Administration today approved the first adjuvanted vaccine for the prevention of H5N1 influenza, commonly known as avian or bird flu.
FDA Permits Marketing of First US Test Labeled for Simultaneous Detection of Tuberculosis Bacteria and Resistance to the Antibiotic Rifampin
The US Food and Drug Administration today allowed marketing of the Xpert MTB/RIF Assay, the first FDA-reviewed test that can simultaneously detect bacteria that cause tuberculosis (TB) and determine if the bacteria contain genetic markers that makes them resistant to rifampin, an important antibiotic for the treatment of TB.
FDA Approves Vibativ
The US Food and Drug Administration today expanded the approved use of the antibiotic Vibativ (telavancin) to treat patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by Staphylococcus aureus.
FDA Approves TOBI Podhaler
The US Food and Drug Administration today approved TOBI Podhaler (tobramycin inhalation powder) for the management of cystic fibrosis patients with Pseudomonas aeruginosa, a bacterium that causes lung infections.
FDA approves new seasonal influenza vaccine made using novel technology
The US Food and Drug Administration today announced that it has approved Flublok , the first trivalent influenza vaccine made using an insect virus ( baculovirus ) expression system and recombinant DNA technology. Flublok is approved for the prevention of seasonal influenza in people 18 through 49 years of age.
FDA Approves Sirturo as Tuberculosis Option
On Dec. 28, the US Food and Drug Administration approved Sirturo ( bedaquiline ) as part of combination therapy to treat adults with multi-drug resistant pulmonary tuberculosis (TB) when other alternatives are not available.
FDA expands Tamiflu’s use to treat children younger than 1 year
The US Food and Drug Administration today expanded the approved use of Tamiflu (oseltamivir) to treat children as young as 2 weeks old who have shown symptoms of flu for no longer than two days.