Peginterferon Lambda Gets Breakthrough Tx Status for Hepatitis D
The FDA has granted Breakthrough Therapy designation to peginterferon lambda (Lambda; Eiger BioPharmaceuticals) for the treatment of hepatitis delta virus (HDV) infection.
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FDA-Approved Generic Version of EpiPen Jr Now Available
The FDA-approved generic version of EpiPen Jr (epinephrine injection; Mylan) Auto-Injector 0.15mg is now available, according to Teva Pharmaceuticals.
Investigational Zika Vaccine Gets Fast Track Status
An investigational messenger RNA (mRNA) vaccine to prevent Zika virus infection has been granted Fast Track designation by the Food and Drug Administration.
FDA Approves First-In-Class Antibiotic to Treat Community-Acquired Bacterial Pneumonia
The FDA has approved Xenleta (lefamulin; Nabriva Therapeutics) for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.
Neuromodulation Device Approved for Patients With Advanced Heart Failure
The device includes an implantable pulse generator (IPG), a carotid sinus lead kit and a programmer.
FDA Rejects sNDA for Hetlioz in Jet Lag Disorder
The FDA has rejected the supplemental New Drug Application for Hetlioz (tasimelteon; Vanda Pharmaceuticals) for the treatment of jet lag disorder.
AHA: Prescription Omega-3 Fatty Acids Effectively Lower Triglycerides
4 g daily EPA+DHA or EPA only effective and safe for use as monotherapy or in combination
Rinvoq Approved for Moderate to Severe Rheumatoid Arthritis
The approval was based on data from five phase 3 trials (the SELECT program) involving approximately 4400 patients with moderate to severe RA, including those who failed or were intolerant to biologic disease-modifying antirheumatic drugs.
Several Transcatheter Heart Valves Get FDA Approval for Low-Risk Patients
Previously, these transcatheter valves were only indicated for patients at intermediate or higher risk for death or major complications during open-heart surgery.
Spinal Tether Device Approved for Scoliosis Treatment
The FDA has approved a unique device for pediatric patients with idiopathic scoliosis who have not responded to conservative treatment options.
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