Articles tagged with "FDA"

FDA Teams with Medical Companies in Puerto Rico to Tackle Shortages

Reuters Staff | October 22, 2017

(Reuters)—The head of the U.S. Food and Drug Administration said the agency was working with several pharmaceutical and medical device companies in Puerto Rico to prevent shortages of medical products in the U.S. as it joins a massive effort to help rebuild the island that was ravaged by Hurricane Maria.1 Drugmakers are working to get…

Rheumatology Drug Updates: Biosiomilar to Adalimumab Receives FDA Approval; plus Updates on Baricitinib, Tofacitinib, Bimekizumab

Mary Beth Nierengarten | October 17, 2017

FDA Approves Adalimumab-adbm On Aug. 29, the FDA approved Cyltezo (adalimumab-adbm), a biosimilar to Humira (adalimumab).1 Cyltezo was approved as a prefilled syringe to treat multiple chronic inflammatory diseases, including moderate to severe active RA, active psoriatic arthritis and ankylosing spondylitis, and moderate to severe plaque psoriasis. The treatment has also been approved for moderate…

Flexion’s Knee Pain Drug Gets FDA Approval

Divya Grover | October 9, 2017

(Reuters)—Flexion Therapeutics Inc. said its injectable drug to treat osteoarthritis-related knee pain was approved by the U.S. Food and Drug Administration. The approval comes at a time when U.S. federal authorities are implementing a slew of measures to combat opioid abuse, with President Donald Trump in August declaring the opioid epidemic a national emergency. The…

Efficacy Studied Following Accelerated Drug Approvals

Michele B. Kaufman, PharmD, BCGP | October 2, 2017

In recent years, the number of drugs to receive accelerated FDA approval has increased. A new study examined whether these drugs have demonstrated efficacy in post-approval trials…

FDA Approves Lesinurad + Allopurinol

Michele B. Kaufman, PharmD, BCGP | September 19, 2017

Duzallo, a combination of lesinurad and allopurinol, was approved by the FDA in August to treat hyperuricemia associated with gout…

Abatacept Approved for Psoriatic Arthritis in Adults; Sirukumab Approval Stalls

Michele B. Kaufman, PharmD, BCGP | September 17, 2017

Abatacept Approved for Adult PsA On June 30, the U.S. Food and Drug Administration (FDA) approved abatacept (Orencia) to treat adults with active psoriatic arthritis (PsA).1 Abatacept is available as both an intravenous formulation and a subcutaneous injection.2 The approval was based on results of two randomized, double-blind, placebo-controlled trials, PsA-I and PsA-II, during which…

FDA Update: Biosiomilar to Adalimumab Receives FDA Approval

Michele B. Kaufman, PharmD, BCGP | September 6, 2017

The FDA has approved adalimumab-adbm, a biosimilar, to treat multiple chronic inflammatory diseases…

FDA Committee Recommends Tofacitinib Approval

Michele B. Kaufman, PharmD, BCGP | August 22, 2017

The FDA Arthritis Advisory Committee voted 10 to 1 to recommend approval of tofacitinib to treat psoriatic arthritis…

Flimsy Evidence Behind Many FDA Approvals

Will Boggs, MD | August 21, 2017

(Reuters Health)—Many drugs granted accelerated approval by the U.S. Food and Drug Administration (FDA) lack clear evidence of safety and effectiveness, and the same is true for most high-risk medical devices, according to two new reports in JAMA, online Aug. 15. The Accelerated Approval pathway makes potentially promising investigational medicines available for use before the…

FDA Approves Duzallo for Hyperuricemia in Patients with Uncontrolled Gout

Reuters Staff | August 21, 2017

(Reuters)—Ironwood Pharmaceuticals Inc. said on Monday the U.S. Food and Drug Administration (FDA) approved its oral drug to treat a condition associated with gout. The company’s once-daily drug, Duzallo (lesinurad and allopurinol), was approved to treat hyperuricemia in patients with gout, Ironwood said. Duzallo combines the standard-of-care treatment, allopurinol, with Ironwood’s lesinurad to treat inefficient…