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# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-82/
- Published: 2019-02-10T12:00:00.000Z
- Updated: 2026-09-15T01:02:16.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139149

**DEVICES**

FDA has cleared a Tyber Medical 510(k) for TyFix, an all-in-one extremity joint fixation system. The device is designed to eliminate the use of the ancillary instrumentation for a wide range of bone fixation procedures, including hammertoe correction, according to the company. In addition, the all-in-one sterile-packed device eliminates traditional reprocessing costs, it says. The TyFix screw combines a bone thread with a barbed head to maximize bone compression in both the proximal and distal phalanges. It features cannulated implants with diameters ranging from 1.5- 4.0mm in multiple lengths as well as a straight and an angled 10 degree option.

FDA has cleared a Royal Philips 510(k) for the Philips BlueControl wearable light therapy device to treat mild psoriasis. “Clinical studies have demonstrated that the UV-free blue LED light emitted by Philips’ BlueControl wearable device induces natural, drug-free processes in the skin to significantly reduce symptoms of mild psoriasis vulgaris — the most common form of psoriasis — such as redness, scaling and thickness of psoriasis plaques,” the company says. It is designed for patients to wear the rechargeable, battery-powered device on affected areas such as the arms, legs, elbows and knees using its adjustable straps, the company says.

**DRUGS**

FDA has approved an Amgen supplemental BLA for Blincyto (blinatumomab) to include overall survival data from the Phase 3 TOWER study. The approval converts Blincyto’s accelerated approval to a full approval. The sBLA approval also included data from the Phase 2 ALCANTARA study supporting the treatment of patients with Philadelphia chromosome-positive relapsed or refractory B-cell precursor acute lymphoblastic leukemia. (ALL). Additionally, the approval expands the therapy’s indication for treating relapsed or refractory B-cell precursor ALL in adults and children.

FDA has approved a Janssen Biotech BLA for Tremfya (guselkumab) for treating adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Tremfya works by selectively blocking IL-23, a cytokine that plays a key role in plaque psoriasis. Approval follows an expedited regulatory review under the agency’s priority review voucher program, and it was based on data showing the patients treated with the therapy experienced significant improvement in skin clearance and greater improvement in symptoms of plaque psoriasis including itch, pain, stinging, burning and skin tightness when compared with placebo at week 16.