News & Insights

THOUSAND OAKS, Calif.--(BUSINESS WIRE)---- $ATRA #CART--Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the EBVALLOTM (tabelecleucel) Biologics License Application (BLA) as monotherapy treatment for adult and ped

IRVINE, Calif.--(BUSINESS WIRE)--Masimo Corporation (Nasdaq: MASI) today announced select preliminary financial results for the fourth quarter and full-year ended December 28, 2024 and provided estimates for its full-year 2025 guidance. Preliminary Fourth Quarter 2024 Financial Results: Consolidated revenue is expected to be approximately $601 million, representing 9% growth on a reported and constant currency basis(1); Healthcare revenue is expected to be approximately $368 million, representi

CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX) today announced the completion of the submissions of its marketing authorization applications (MAA) for ANKTIVA® (nogapendekin alfa inbakicept) plus Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors, to both the European Union (EU) European Medicines Agency (EMA) and the United King

CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced significant progress in its ongoing discussions with the U.S. Food and Drug Administration (FDA) regarding three areas of its clinical development pipeline in non-muscle invasive bladder cancer (NMIBC) and non-small cell lung cancer (NSCLC). NMIBC BCG Unresponsive Papillary Disease: ImmunityBio is preparing to submit a supplemental Biologics License Application (sBLA) in 2025

ALISO VIEJO, Calif.--(BUSINESS WIRE)--Glaukos Corporation (NYSE: GKOS), an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced several positive clinical updates for its iDose® sustained-release procedural pharmaceutical platform, including: In a new 36-month follow-up analysis of its two Phase 3 pivotal clinical trials, iDose TR (travoprost intracameral implant) 75 mcg, an FDA-

SANTA FE SPRINGS, Calif.--(BUSINESS WIRE)--Applied BioCode, a leader in molecular diagnostics panel testing, is excited to announce a significant enhancement to its BioCode® Gastrointestinal Pathogen Panel (GPP) with the addition of nucleic acid extraction claim for the widely adopted ThermoFisher Scientific KingFisher™ Flex platform. This expansion enables greater workflow flexibility and optimized sample processing capabilities for clinical laboratories running the BioCode® GPP. This enhancem

LAKE FOREST, Calif.--(BUSINESS WIRE)--STAAR Surgical Company (NASDAQ: STAA), the global leader in phakic IOLs with the EVO family of Implantable Collamer® Lenses (EVO ICL™) for vision correction, today announced that it will release financial results for the fourth quarter and fiscal year ended December 27, 2024, on or about Wednesday, February 19 after the market close. “Our industry-leading EVO ICL technology and market-building initiatives supported our ability to achieve double-digit year-o

OKLAHOMA CITY & TORRANCE, Calif.--(BUSINESS WIRE)--This new collaboration provides a scalable, integrated solution for developing and manufacturing complex peptide drugs efficiently.

IRVINE, Calif.--(BUSINESS WIRE)-- #ClinicalTrials--Immunis, Inc., a clinical-stage biotech developing multi-active biologics for age and disease-related immune dysregulation, has closed a $25 million Series A-1 financing round to fund two Phase 2 clinical trials. Follow-on investments from all major existing investors, notably, Remiges Ventures, Continuum Health Ventures and BOLD Capital Partners were joined by new investments from LifeSpan Vision Ventures and JLS Fund among others, including a leading global in

SANTA MONICA, Calif.--(BUSINESS WIRE)--GoodRx (Nasdaq: GDRX), the leading prescription savings platform in the U.S., today announced it is offering free online healthcare provider visits to California residents impacted by the wildfires devastating Los Angeles County. Starting today, Angelenos can use the code LA-GOODRX-CARE to be seen by a licensed medical provider on GoodRx Care for a variety of conditions. Hundreds of thousands of Californians have been impacted by the wildfires, which may p

SOUTH SAN FRANCISCO, Calif. & LOS ANGELES & SAN DIEGO--(BUSINESS WIRE)--Biocom California, the association representing the California life science industry, today announced that it appointed Aliza Apple, Ph.D., a vice president of Catalyze360 AI/ML at Eli Lilly; Carolyn Ng, Ph.D., business unit partner at TPG Life Sciences Innovations; and Nancy Whiting, Pharm.D., president and CEO at Recludix Pharma, to its board of directors. Additionally, Tim Scott has assumed his role as CEO and president

IRVINE, Calif.--(BUSINESS WIRE)--TAE Life Sciences, in collaboration with Kyoto University and Principal Investigator Dr. Fuyuhiko Tamanoi, is pleased to announce groundbreaking preclinical results in Boron Neutron Capture Therapy (BNCT). Utilizing TAE Life Science’s novel boron-10 drugs and Kyoto University Research Reactor (KURR) neutron source has generated significant pre-clinical data that may redefine the potential of BNCT in cancer treatment. Recently published in the Journal of Medicina

AGOURA HILLS, Calif.--(BUSINESS WIRE)--A2 Biotherapeutics, Inc. (A2 Bio), a clinical-stage cell therapy company developing first-in-class logic-gated cell therapies to selectively target tumor cells and protect normal cells, today announced the closing of its $80 million Series C financing round, supported by a syndicate of investors that includes The Column Group and Samsara BioCapital. Proceeds will fund the company’s three clinical development programs and advancement of its pipeline of CAR-

IRVINE, Calif. & AMSTERDAM--(BUSINESS WIRE)--Agendia®, Inc. today provided a topline review of the company’s key milestone achievements in 2024. These updates include significant inroads in expanding market access, product innovation, commercial growth, advancements in research, as well as key partnerships and awards. “In the past year, Agendia has made great progress in advancing the field of precision oncology and genomic testing. We have seen success across multiple aspects of our business,

ALISO VIEJO, Calif.--(BUSINESS WIRE)--Ambry Genetics, a leader in clinical genomic testing, today announced its contribution to a study published in Nature that significantly advances our understanding of BRCA2 gene variants. As the uptake of genetic testing continues to grow, the need for scalable interpretation of the vast number of variants detected has become critical. This study was designed to leverage CRISPR/cas-9 gene editing to aid in the functional characterization of nearly 7,000 BRC

IRVINE, Calif.--(BUSINESS WIRE)--Masimo (NASDAQ: MASI) today announced that its management will participate in the 43rd Annual J.P. Morgan Healthcare Conference on Thursday, January 16, 2025 at 10:30 a.m. Pacific time. A live webcast of the presentation will be available on the Masimo website at www.masimo.com. A replay of the webcast will be available following the live presentation. About Masimo Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide arr

BELOIT, Wis. & LAGUNA HILLS, Calif.--(BUSINESS WIRE)--NorthStar Medical Radioisotopes, LLC and YAP Therapeutics, Inc. have entered into a collaboration agreement to develop and produce radiopharmaceuticals aimed at treating cancer and other chronic diseases. NorthStar is involved in the development, production, and commercialization of radiopharmaceuticals for therapeutic applications and medical imaging. YAP Therapeutics, a Fjord Ventures company, utilizes its advanced biologic and regenerativ

BELOIT, Wis. & LAGUNA HILLS, Calif.--(BUSINESS WIRE)--NorthStar Medical Radioisotopes and YAP Therapeutics Enter into Collaboration Agreement for Development and Production of Radiopharmaceutical Products

SANTA MONICA, Calif.--(BUSINESS WIRE)--GoodRx (Nasdaq: GDRX), the leading prescription savings platform in the U.S., today announced a new GoodRx for Pets experience that provides a more affordable and convenient way for Americans to access pet medications. Through GoodRx for Pets, pet owners can find savings and have pet medications delivered right to their door. GoodRx for Pets provides a seamless experience for pet owners, combining convenience, affordability, and accessibility in one place.

LOS ANGELES--(BUSINESS WIRE)--Kairos Pharma Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company, announced today that John S. Yu, M.D., Chief Executive Officer, and Neil Bhowmick, Chief Scientific Officer, will present a corporate overview at the Lytham Partners Investor Healthcare Summit. The conference is being held virtually on January 13, 2025. Event: Lytham Partners Investor Healthcare Summit Presentation Date: Monday, January 13, 2025 Time: 2:00 PM ET Webcast Link: http

THOUSAND OAKS, Calif.--(BUSINESS WIRE)--AliveGen USA Inc. (AliveGen), a clinical stage biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to ALG-801 for the treatment of pulmonary arterial hypertension (PAH), a rare, serious, and life-threatening condition characterized by high blood pressure in the lung arteries that can lead to right-sided heart failure. “FDA’s Orphan Drug Designation for ALG-801 underscores the need

IRVINE, Calif.--(BUSINESS WIRE)--Edwards Lifesciences Corporation (NYSE: EW) today announced it will participate in the J.P. Morgan Healthcare Conference on Tuesday, Jan. 14, 2025. Bernard Zovighian, chief executive officer, is scheduled to present at 11:15 a.m. PT. Scott Ullem, chief financial officer, will also participate in the conference. A live webcast of the presentation will be available on the Edwards Lifesciences investor relations website at http://ir.edwards.com/, with an archived v

IRVINE, Calif.--(BUSINESS WIRE)-- #dialysis--Diality, a medical device company developing a smart, flexible hemodialysis platform, today announced successful completion of the first-ever patient treatment with the Moda-flx Hemodialysis System™ in collaboration with North America Research Institute at Ontario-Holt Dialysis Center in Ontario, Calif. “Our partnership with the North America Research Institute is an important step toward delivering on our promise to improve the lives of patients and families af

IRVINE, Calif.--(BUSINESS WIRE)--Endologix LLC, a privately held global medical device company specializing in innovative therapies for vascular disease, today announced a leadership transition. Dr. Matt Thompson will step down as President and Chief Executive Officer and take on a new role as Executive Vice President and Chief Medical Officer. Dr. John Liddicoat has been appointed as the new President and CEO, effective immediately. Richard Mott, Chairman of the Board stated: “We are thrilled

CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced the unique, permanent Healthcare Common Procedure Coding System (HCPCS) J-code assigned by the Centers for Medicare & Medicaid Services (CMS) for ANKTIVA® (nogapendekin alfa inbakicept-pmln) became effective January 1, 2025. The U.S. Food and Drug Administration (FDA) approved ANKTIVA with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unrespo

LOS ANGELES--(BUSINESS WIRE)---- $CDXC #ChromaDex--ChromaDex Corp. (NASDAQ: CDXC), the global authority on nicotinamide adenine dinucleotide (NAD+) with a focus on the science of healthy aging, today announced that it will participate in a webcasted company presentation at the Lytham Partners 2025 Investor Healthcare Summit, taking place virtually on Monday, January 13, 2025. The company presentation will take place at 12:00 p.m. ET on Monday, January 13, 2025. The webcast can be accessed directly at https://lytham

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that on January 2, 2025, the Compensation Committee of Puma’s Board of Directors approved the grant of inducement restricted stock unit awards covering 24,375 shares of Puma common stock to two new non-executive employees. The awards were granted under Puma’s 2017 Employment Inducement Incentive Award Plan, which was adopted on April 27, 2017 and provides for the granting of equity awar

LOS ANGELES--(BUSINESS WIRE)--NCCN Guidelines for Cervical Cancer now include Puma's neratinib monotherapy for 2nd line or later use in patients with HER2-mutated tumors, Cat. 2A.

PASADENA, Calif.--(BUSINESS WIRE)---- $arwr--Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it has dosed the first subjects in a Phase 1/2a clinical trial of ARO-INHBE, the company’s investigational RNA interference (RNAi) therapeutic being developed as a potential treatment for obesity. Arrowhead also filed recently a request for regulatory clearance to initiate a clinical trial for its second obesity candidate, ARO-ALK7. Both ARO-INHBE and ARO-ALK7 are designed to intervene in a kn

ALISO VIEJO, Calif.--(BUSINESS WIRE)--Glaukos Corporation (NYSE: GKOS), an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Epioxa™ (Epi-on), its next-generation corneal cross-linking iLink therapy for the treatment of keratoconus, a progressive, sight-threatening corneal dise

PASADENA, Calif.--(BUSINESS WIRE)---- $arwr--Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that as an inducement to entering into employment with the Company, on December 13, 2024, the Company’s Board of Directors approved “inducement” grants to 20 new employees under Rule 5635(c)(4) of the NASDAQ Listing Rules. The grants entitle employees, in aggregate, to receive up to 44,350 restricted stock units. The grants are outside the Company’s stockholder-approved equity incentive plans and v

HUNTINGTON BEACH, Calif.--(BUSINESS WIRE)--The five-patient FDA Early Feasibility Study of BiVACOR Total Artificial Heart successfully bridges all to a donor heart transplant-EFS expanded to 15

PASADENA, Calif.--(BUSINESS WIRE)--Holoclara initiates Phase 1 clinical trial evaluating worm-derived therapeutic HC002 in healthy adults

PASADENA, Calif.--(BUSINESS WIRE)--Holoclara selects eosinophilic esophagitis as its lead indication for HC002, a first-in-class worm-derived therapy

LOS ANGELES--(BUSINESS WIRE)--For the press release dated December 16, 2024, add caption: Left to Right: Joseph Miller, MD, MS, Director of Interventional Radiology, and Phoenix Hunt, VR Technologist. (Photo: Business Wire) The release reads: CHILDREN’S HOSPITAL LOS ANGELES USES VIRTUAL REALITY TO TRANSFORM MINIMALLY INVASIVE PROCEDURES FOR PATIENTS If your heart rate increases each time you hear the word “injection,” you’re not alone. Every 1 in 4 adults has a fear of needles—a fear that most

EL SEGUNDO, Calif.--(BUSINESS WIRE)--KARL STORZ United States proudly announces its VITOM® eagle exoscope with ARTip CRUISE® motorized holding system has received an Innovative Technology designation from Vizient, Inc., the largest provider-driven healthcare performance improvement company in the country. KARL STORZ exhibited the VITOM eagle and ARTip CRUISE at this year’s Vizient Innovative Technology Exchange in Las Vegas. Each year, healthcare experts serving on Vizient provider-led councils

LOS ANGELES--(BUSINESS WIRE)--Children’s Hospital Los Angeles team finds biomarker combination that could predict liver fibrosis early enough to reverse liver damage.

LONG BEACH, Calif.--(BUSINESS WIRE)---- $RKLB--Rocket Lab has successfully delivered its second Pioneer spacecraft to Vandenberg Space Force Base and completed production of a third for Varda.

ALISO VIEJO, Calif.--(BUSINESS WIRE)--Glaukos Corporation (NYSE: GKOS), an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced that its management is scheduled to participate in the 43rd Annual J.P. Morgan Healthcare Conference on Tuesday, January 14, 2025, at 5:15 p.m. PT in San Francisco, CA. A live and archived webcast for these events, where applicable, will be available in

FOSTER CITY, Calif. & LOS ANGELES--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) and Terray Therapeutics, Inc. announced today that the companies have entered into a strategic collaboration to discover and develop novel, small molecule therapies across multiple targets. Terray’s tNova platform combines high-throughput chemical experimentation and computational analysis with a generative AI-driven drug discovery engine. The company’s iterative approach applies AI-empowered methods to an

LAGUNA HILLS, Calif.--(BUSINESS WIRE)--Adagio Medical Holdings, Inc. (Nasdaq: ADGM; the “Company” or “Adagio”), a leading innovator in catheter ablation technologies for treatment of cardiac arrhythmias, today announced that founder Olav Bergheim departed as Chief Executive Officer (“CEO”) and Chairperson of the Board of Directors of the Company, effective December 13, 2024. Concurrently, the Company announced the appointment of Todd Usen, as Chief Executive Officer and Director of the Company

CALABASAS, Calif.--(BUSINESS WIRE)--Nationwide Medical, a national provider of home medical equipment, announces growth partnership with Heritage Group.

IRVINE, Calif. & AMSTERDAM--(BUSINESS WIRE)--Agendia®, Inc., today announced it will be presenting new data highlighting MammaPrint® and BluePrint® utility in guiding treatment decisions for patients with early-stage breast cancer. The findings will be presented in two spotlight presentations and two posters at the San Antonio Breast Cancer Symposium 2024 (SABCS), on Wednesday, December 11th and Thursday, December 12th. One poster spotlight, titled “Association of MammaPrint® with gene expressi

LOS ANGELES--(BUSINESS WIRE)--LadRx Corporation (OTCQB: LADX) (“LadRx” or the “Company”), a biopharmaceutical innovator focused on research and development of life-saving cancer therapeutics, is pleased to announce that the Company is restarting a process to seek marketing approval of aldoxorubicin under the provisions of the FDA’s Section 505(b)(2). The 505(b)(2) pathway is designed for a new drug composition whose active ingredient is the same active ingredient as a drug previously approved b

IRVINE, Calif. & AMSTERDAM--(BUSINESS WIRE)--Agendia®, Inc., today announced it will be presenting new data from the Real-World Data Registry, FLEX, demonstrating MammaPrint®’s ability to predict chemotherapy benefit in patients with HR+HER2- early-stage breast cancer. The findings will be presented at the San Antonio Breast Cancer Symposium 2024 (SABCS), on Wednesday, December 11th. The study, presented by Adam Brufsky, MD, PhD, Professor and Associate Chief of Hematology and Oncology at UPMC

PASADENA, Calif.--(BUSINESS WIRE)---- $arwr--Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced interim results from a Phase 1/2a clinical study of ARO-CFB, the company’s investigational RNA interference (RNAi) therapeutic targeting complement factor B being developed as a potential treatment for complement mediated diseases. The data were presented today, December 11, 2024, at the 8th Complement-Based Drug Development Summit being held in Boston. “Dysregulated activation of the complement sy

CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced the pricing of its previously announced underwritten public offering of an aggregate of 33,333,334 shares of its common stock at a price to the public of $3.00 per share. ImmunityBio has granted the underwriters a 30-day option to purchase up to an additional 5,000,000 shares of its common stock at the public offering price, less underwriting discounts and commissions. All of

CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced that it intends to offer and sell, subject to market and other conditions, shares of its common stock in an underwritten public offering. In addition, ImmunityBio expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the offering at the public offering price, less underwriting discounts and commissions.

LOS ANGELES--(BUSINESS WIRE)--Researchers from City of Hope®, one of the largest and most advanced cancer research and treatment organizations in the United States, whose Los Angeles comprehensive cancer center is ranked among the nation’s top 5 cancer centers by U.S. News & World Report, presented new study results on treatment options, side effect prevention and risk prediction for blood cancer patients at this year’s ASH conference in San Diego, California, held Dec. 7 to 10. Scientists

EL SEGUNDO, Calif.--(BUSINESS WIRE)--KARL STORZ United States, a leader in surgical innovation and operating room (OR) integration, announces the US launch of Pathway.AI, a new tool powered by the Artisight Smart Hospital Platform. By detecting and responding to status changes in the OR, Pathway.AI may help reduce turnover times and eliminate many manual tasks, thereby enhancing OR efficiency and increasing data accuracy. “Artisight’s expertise in healthcare AI is the perfect complement to KARL