Clearside Biomedical announced that the Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Xipere (triamcinolone acetonide ophthalmic suspension) for Suprachoroidal Injection for the treatment of macular edema associated with uveitis.
It is designed to release fluocinolone acetonide, a corticosteroid, at an initial rate of 0.25mcg/day.
TriVisc contains highly purified hyaluronic acid that helps supplement the viscous properties of the fluid in the knee joint.
Data from a phase 2 trial of baricitinib for the treatment of SLE supporting the Fast Track designation were published in The Lancet and presented at the European Congress of Rheumatology earlier this year.
Currently, same-day delivery is available only in Dallas, Chicago, New York City, Gainesville, Miami, Tampa, and Fort Lauderdale; this program will be expanded in 2019.
Genentech announced that the FDA has approved ACTPen autoinjector for Actemra as a new formulation for adults with moderate to severe active RA.
This guidance, updated for the first time since 2008, provides evidence-based recommendations for children (ages 3-17) and adults.
The FDA has approved the first direct-to-consumer test to detect genetic variants that may be associated with a patient’s ability to metabolize certain medications.
The FDA’s approval was supported by data from analytical, preclinical, and clinical research showing that Hyrimoz matched the reference product’s safety, efficacy, and quality.
Clinical enrollment for an open-label, single-arm Phase 1/2 trial of FCX-013 was initiated in August 2018.
