Industry

ImmunityBio Announces FDA Acceptance of Supplemental BLA for ANKTIVA® Plus BCG in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer with Papillary Disease; PDUFA Date Set for January 6, 2027

Supplemental BLA seeks to expand the ANKTIVA label to include patients with BCG-unresponsive NMIBC with papillary disease FDA noted in its filing communication that the supplemental BLA accepted for review was based on the additional scientific data ImmunityBio provided at the Agency’s request, detailing the overlapping features of papillary and CIS disease to determine adequate … [Read more…]

MedTech Innovator Asia Pacific Selects Top 20 Startups for 2026 APAC Accelerator Program from 680+ Applicants

Selected companies represent the top 3% of applicants and will join the eighth annual APAC Accelerator Program, gaining access to mentorship, industry partners, investors, and market access support across the region and globally. LOS ANGELES & SINGAPORE–(BUSINESS WIRE)–#HealthtechInnovation–MedTech Innovator, the world’s largest accelerator of medical technology companies, today announced that 20 high-potential medtech companies have … [Read more…]

HealthView CEO Steven Gonzalez Announces Inc. Articles on Why Presence Beats Certainty — and Why It Matters Even More in the Age of AI

Latest article challenges the myth of confident leadership; upcoming piece explores how AI reshapes the case for human presence CERRITOS, Calif.–(BUSINESS WIRE)–#BusinessStrategy–Steven Gonzalez, President & CEO of HealthView Home Health, Hospice & Palliative Care, announces the publication of his latest Inc. article, “Certainty Is Overrated. Presence Is Underrated,” now live on Inc.com. A follow-up piece, … [Read more…]

ZS Advances Agentic AI Applications for Life Sciences With Launch of ZAIDYN Medical™ and ZAIDYN Content™

Building on decades of life sciences expertise, ZS is scaling agentic AI from strategy to governed execution across medical and commercial workflows. EVANSTON, Ill.–(BUSINESS WIRE)–ZS, a global management consulting and technology firm, today announced its expansion of ZAIDYN®, a life sciences intelligence platform powered by agentic AI. The expansion introduces ZAIDYN Medical™ and ZAIDYN Content™—two … [Read more…]

Wolters Kluwer Medi-Span Selected to Provide Personalized Medication Decision Support at The Christie NHS Foundation Trust

Roll-out at largest EU cancer center marks first Medi-Span NHS implementation WALTHAM, Mass. & COPENHAGEN–(BUSINESS WIRE)–#healthcare—Wolters Kluwer Health has implemented its industry-leading medication decision support (MDS) solution, Medi-Span®, at the world-renowned specialist oncology center, The Christie NHS Foundation Trust. “The Christie is recognized globally for its excellence and commitment to delivering exceptional patient care,” says … [Read more…]

InterSystems IntelliCare Becomes the First AI-Native EHR to Achieve EU Medical Device Regulation Certification

Regulatory milestone reaffirms InterSystems as a leading provider of enterprise-grade AI applications BOSTON–(BUSINESS WIRE)–InterSystems, a creative data technology provider powering more than one billion health records globally, today announced that its electronic health record (EHR) solutions have been certified as Class IIa Medical Devices under Regulation (MDR) certification under Regulation (EU) 2017/745. This approval marks … [Read more…]

Bayer Granted Priority Review by U.S. FDA for Asundexian in Patients After a Non-Cardioembolic Ischemic Stroke or Transient Ischemic Attack

KEY FACTS: Regulatory submission is based on positive results from the Phase III OCEANIC-STROKE study OCEANIC-STROKE met the primary efficacy outcome of time to first occurrence of ischemic stroke and the primary safety outcome of time to ISTH (International Society on Thrombosis and Haemostasis) major bleeding WHIPPANY, N.J.–(BUSINESS WIRE)–Bayer: WHAT’S HAPPENING Bayer today announced that … [Read more…]

Azafaros Strengthens Leadership Team With Appointment of Amy Sullivan as Chief Financial Officer

Experienced biotech finance leader with over 30 years’ experience in capital markets and strategy Proven track record in fundraising, M&A and company transformation Company is currently running two pivotal Phase 3 studies with nizubaglustat in GM1/ GM2 gangliosidoses and Niemann-Pick type C disease LEIDEN, Netherlands–(BUSINESS WIRE)–#Adults—Azafaros, a private company building a portfolio to become a … [Read more…]

Kin Health Raises $9M To Give Patients a Record of Their Own Care

Founded by practicing physicians, Kin translates medical appointments into plain language, allowing patients to build a personal health record from the only source that actually works LOS ANGELES–(BUSINESS WIRE)–Kin Health, a free app that allows patients to remember and act upon doctors’ advice, today announced a $9 million seed round led by Maveron, with participation … [Read more…]

Maravai LifeSciences To Attend The Jefferies Global Healthcare Conference

SAN DIEGO–(BUSINESS WIRE)–Maravai LifeSciences, Inc. (NASDAQ: MRVI), a global provider of life science reagents and services to researchers and biotech innovators, today announced that the Company will participate in the following investor conference in June. On June 4, 2026, at 12:50 p.m. Eastern Time, Raj Asarpota, Chief Financial Officer, will participate in a fireside chat … [Read more…]