Sanofi announced today that the FDA approved the delivery of its Sarclisa anticancer therapy through the Enable Injections on-body device. Sarclisa (isatuximab-irfc) Escena in combination with standard-of-care regimens received clearance for the treatment of patients with multiple myeloma (MM) across all existing indications of the Sarclisa intravenous (IV) formulation. Approval makes it the first anticancer […]
Oncology
Johnson & Johnson wins FDA nod for intravesical drug delivery tech
![The Inlexzo system. [Image courtesy of Johnson & Johnson]](https://www.drugdeliverybusiness.com/wp-content/uploads/2025/09/Inlexzo-JJ-2-1-150x86.jpg)
Johnson & Johnson (NYSE:JNJ) announced today that the FDA approved Inlexzo, its gemcitabine intravesical drug delivery system. The intravesical gemcitabine-releasing system, previously known as TAR-200, treats patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. A healthcare professional places TAR-200 into the bladder […]
Johnson & Johnson wins FDA priority review for drug delivery system
Johnson & Johnson (NYSE:JNJ) announced today that the FDA granted priority review to a new drug application (NDA) for its TAR-200. TAR-200, an intravesical gemcitabine-releasing system, treats patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. A healthcare professional places TAR-200 into the […]
TriSalus Life Sciences launches new infusion system
TriSalus Life Sciences (Nasdaq:TLSI) announced today that it launched its new TriNav FLX infusion system. TriNav FLX features enhanced trackability and significantly expands the company’s existing TriNav portfolio of products. It offers interventional radiologists more options to select the right product for the right patient, TriSalus said in a news release. According to TriSalus, the […]
RenovoRx prices $12.1M offering
RenovoRx (Nasdaq:RNXT) announced that it priced an underwritten public offering of common stock worth proceeds of $12.1 million. Mountain View, California-based RenovoRx priced more than 11.5 million shares of common stock at $1.05 per share. It expects the proceeds to total approximately $12.1 million before deducting underwriting discounts, commissions and offering expenses. The company plans […]
Boston Scientific to acquire hepatic artery infusion pump maker Intera Oncology
Boston Scientific (NYSE:BSX) announced today that it agreed to acquire infusion pump maker Intera Oncology for an undisclosed amount. Intera Oncology develops the Intera 3000 hepatic artery infusion pump and floxuridine, a chemotherapy drug. Both hold FDA approval. The pump administers hepatic artery infusion (HAI) therapy to treat tumors in the liver primarily caused by […]
RenovoRx to increase production of RenovoCath catheter delivery system
RenovoRx announced today that it plans to increase the production of its RenovoCath catheter-based delivery system. The Los Altos, California-based company cited increased demand for the delivery of diagnostic and/or therapeutic agents. It signed a new project work order with its principal manufacturing partner, Medical Murray, providing for an expanded relationship. The company looks to […]
Sirtex Medical begins European launch for microsphere delivery system following EU approval
Sirtex Medical announced today that it received EU MDR certification to market its SIR-Spheres Y-90 resin microspheres and delivery systems. EU MDR authorization enables Woburn, Massachusetts-based Sirtex to kick off a European launch for its Siros delivery system. Siros offers an intuitive, visual and adaptable solution for physicians to administer SIR-Spheres to liver cancer patients. […]
ICU Medical closes Minnesota facility, cuts 83 jobs
ICU Medical (Nasdaq: ICUI) filed with the state of Minnesota to confirm the termination of 83 employees following a facility closure. Minnesota’s State Rapid Response Team received a Worker Adjustment and Retraining Notification (WARN) letter from the maker of technologies for infusion therapy, oncology and critical care dated today, July 16. The letter outlined plans to […]
Carthera wins U.S., EU orphan drug designation for SonoCloud
Carthera announced today that it received FDA and European orphan drug designation (ODD) for the use of carboplatin with its SonoCloud. The designation allows Paris, France-based Carthera to use carboplatin chemotherapy in the treatment of malignant glioma. Carthera conducts this treatment through the use of SonoCloud, a device that emits ultrasound to temporarily increase the […]
