Tag Archives: Approved

Will Canada approve a first-dose-first strategy now that AstraZeneca has been approved?

Breadcrumb Trail Links News Health Canada The U.K.’s controversial strategy to space vaccine doses up to three months apart could see everyone offered a first dose by end of July — months sooner than Canada Author of the article: Sharon Kirkey Publishing date: Feb 26, 2021  •  2 days ago  •  4 minute read  •  67… Read More »

Tremfya (guselkumab) Approved by U.S. Food and Drug Administration as the First Selective Interleukin (IL)-23 Inhibitor for Active Psoriatic Arthritis

Print this page HORSHAM, PA, July 14, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for adult patients with active psoriatic arthritis (PsA), a chronic progressive disease characterized by painful joints and skin inflammation.[1],[2] Tremfya is the first treatment… Read More »

Qinlock (Ripretinib) Approved as Fourth-Line Treatment for GIST

MONDAY, May 18, 2020 — The U.S. Food and Drug Administration approved Qinlock (ripretinib) tablets as a fourth-line treatment for adults with advanced gastrointestinal stromal tumors (GISTs), the agency announced Friday. The approval follows four other FDA-approved target therapies for GIST, including imatinib in 2002, sunitinib in 2006, regorafenib in 2013, and avapritinib in January.… Read More »

Emgality Approved to Treat Episodic Cluster Headache in Adults – Medical Bag

The Food and Drug Administration (FDA) has approved Emgality (galcanezumab-gnlm; Lilly) for injection for the treatment of episodic cluster headache in adults. The approval was based on the results from a phase 3 double-blind, placebo-controlled trial that included 106 patients diagnosed with episodic cluster headaches. Patients were randomized to receive either once-monthly Emgality 300mg administered… Read More »

Fast-Acting Depression Drug, Newly Approved, Could Help Millions

Of the 16 million American adults who live with depression, as many as one-quarter gain little or no benefit from available treatments, whether drugs or talk therapy. They represent perhaps the greatest unmet need in psychiatry. On Tuesday, the Food and Drug Administration approved a prescription treatment intended to help them, a fast-acting drug derived… Read More »