This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product The FDA is aware that Alcon has issued a letter to affected customers recommending certain Alcon Custom Paks be removed from where they are used or sold. Affected devices: What to Do Locate and dispose of any affected lots of Alcon Custom Pak remaining in your inventor

SEATTLE, Jan. 2, 2026 /PRNewswire/ -- BrainSpace, a medical technology company building automated solutions for neuro injury, illness and degeneration, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Intellidrop, an automated brain fluid management system integrating proprietary hardware and software to achieve continuous brain pressure measurement and closed-loop, gravity-driven, precision drainage of brain fluid to a personalized volume or pres

ALLENTOWN, PA, UNITED STATES, January 2, 2026 / EINPresswire.com / -- OctoNerv LLC, a privately held medical technology company based in Allentown, Pennsylvania, announced the completion of a functional electronic prototype as part of its ongoing research and development efforts focused on reconstructive and restorative healthcare innovation. The prototype supports the company’s work on the Electronic Breast Nipple Implant (EBNI), a research-stage medical device concept being explored to address

Issued on behalf of Avant Technologies Inc. VANCOUVER, BC, Jan. 2, 2026 /PRNewswire/ -- Equity Insider News Commentary – The gene therapy market is surging toward $36.55 billion by 2032, powered by rising demand for curative treatments that target genetic diseases at their source[1]. The FDA approved three transformative cell therapies this December alone, marking an inflection point where living medicine moves from experimental concept to commercial reality[2]. This revolution in restorative bi

ROCKWALL, Texas, Jan. 2, 2026 /PRNewswire/ -- United Vein & Vascular Centers (UVVC), a national leader in minimally invasive vein and vascular care, is proud to announce the official opening of its newest clinic in Rockwall, Texas, expanding access to expert outpatient care across the northeast Dallas area. Beginning today, patients can visit the new facility located at 1005 W Ralph Hall Parkway, Suite 221, Rockwall, TX 75032, for advanced, personalized treatment of vein and vascular conditions.

ADZYNMA (ADAMTS13, recombinant-krhn) Neutralizing antibodies with fatal outcome FDA is evaluating the need for regulatory action. FDA Safety Communication was issued on November 21, 2025: FDA Investigating Death Due to Neutralizing Antibodies to ADAMTS13 following Adzynma Treatment of Congenital Thrombotic Thrombocytopenic Purpura Asceniv (immune globulin intravenous, human-slra) Increased hypersensitivity reactions in patients receiving certain product lot FDA is evaluating the need for regulat

DUBLIN--(BUSINESS WIRE)--The "The Pharma Mini MBA Training Course (Mar 18th - Mar 20th, 2026)" training has been added to ResearchAndMarkets.com's offering. Working in the highly competitive pharmaceutical industry, with ever-increasing change and pressure, is probably one of the most challenging managerial roles of any industry today. This event has been especially designed to help you transcend these challenges by training you to become equipped to see the bigger picture in all aspects of your

DUBLIN--(BUSINESS WIRE)--The "Selecting the Best Scientific Journal for Your Research Training Course (Apr 13, 2026)" training has been added to ResearchAndMarkets.com's offering. This session offers a detailed guide to selecting the most appropriate scientific journal for your research, ensuring alignment with your study's scope, audience, and academic goals. Participants will learn how to distinguish between predatory journals, which lack rigorous peer review standards, and authentic, reputabl

Hundreds of thousands of families with young children will be offered protection against chickenpox as part of their routine childhood vaccinations from today. The NHS’s vaccination programme is being expanded to include chickenpox (also known as varicella) for the first time to help shield young children from getting seriously ill. From now on, GP practices will start to offer children a combined MMRV vaccine at 12 months and 18 months of age to add chickenpox to the protections against measles

Check back to this tracker for regulatory updates on marketed drugs, including expansions into new geographies and indications. Welcome to Fierce Pharma's regulatory tracker for the first half of 2026. On this page, we're recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Be sure to come back regularly for the latest updates.UPDATED: Friday, January 2 at 9:40 a.m. After receiving prior FDA rejections in 2023 and mi