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MinuteClinic highlights improved access and outcomes through its clinically supervised weight-loss program

care expenditures." MinuteClinic can also serve as a primary care provider to eligible patients 18 and older. Launched in 2024 and continuing to expand across the U.S., MinuteClinic Primary Care enables providers to identify and manage related...

BIZENGRI® (Zenocutuzumab-zbco) Wins FDA Approval for NRG1 Fusion-Positive Cholangiocarcinoma, Says Partner Therapeutics

patients are appropriately identified for targeted therapy." BIZENGRI was first approved under accelerated approval in 2024 in advanced, unresectable or metastatic non-small cell lung cancer and pancreatic adenocarcinoma for patients harboring an...

NurtureBio Launched Breast Milk–Inspired Synbiotic to Help Babies with Gut Issues

(HMOs) and targeted probiotic strains to support digestive and immune health in infants and toddlers. Founded in 2024 by Stuart Smith, a parent motivated by firsthand experience, the company collaborates with leading breast milk and microbiome...

UCB to acquire Candid Therapeutics, strengthening its immunology pipeline with novel T-cell engagers

by targeting different B-cell protein targets, as well as evaluating different depths of B-cell depletion. Established in 2024 and headquartered in San Diego, CA, Candid is led by a team of entrepreneurial executives who have a track record of...

Cellenkos, Inc. receives FDA clearance to begin Phase 2 trial of CK0801 (allogeneic cord blood-derived Tregs) for aplastic anemia

CK0801 Phase 1 Trial Outcomes Phase 1 results for CK0801 in bone marrow failure syndromes were published in NEJM Evidence (2024). In that study of 9 enrolled patients (4 with aplastic anemia, 4 with myelofibrosis, and 1 with hypoplastic...

CRENESSITY® lowers glucocorticoid doses while maintaining androgen control in adults with classic congenital adrenal hyperplasia

from the CAHtalyst Phase 3 studies supported approval of CRENESSITY by the U.S. Food and Drug Administration in December 2024. The open-label extension treatment portions of both studies are ongoing. Important Information Approved Uses CRENESSITY®...

Emerging From Stealth, Oryon Cell Therapies Targets Autologous Neuron Replacement for Parkinson’s Disease and Neurodegenerative Disorders

including Parkinson’s disease and multiple sclerosis. Merz Therapeutics acquired the company's commercial portfolio in 2024. Previously, Dr. Cohen was a principal in the startup and an officer of Advanced Tissue Sciences, Inc., a biotechnology...

Unique Mouse Model Enables genOway to Transform Prediction of Antibody Therapies in Humans

and its scientific partners, in which multiple FcγR genes were humanized. Since its launch to the scientific community in 2024, genO-hFcγR has been adopted to advance preclinical programs of biopharmaceutical companies and nonprofit organizations,...

ENFLONSIA™ (clesrovimab) shows positive new results in infants and children under 2 at increased risk of severe RSV disease across two seasons, Merck reports

subsequent global regulatory approvals. Interim data from RSV season 1 of the SMART trial were also presented at IDWeek 2024 and published in the New England Journal of Medicine. The SMART trial enrolled infants at increased risk of severe RSV...

New ECCO data demonstrate that subcutaneous infliximab (Remsima™ SC) recaptures and maintains disease control following a drug holiday

treatment options by providing high consistency in drug exposure and a convenient method of administration.2,3 In July 2024, CT-P13 SC received final approval from the European Commission for an additional dosing regimen and dose escalation, which...

China approves Libevitug, first-in-class therapy for hepatitis D

12 million) of people who have a chronic infection with HBV. Given the severe consequences of HDV infection, WHO's 2024 Guidelines for the prevention, diagnosis, care and treatment for people with chronic hepatitis B infection recommend that...

Ad Hoc Analyses Indicate Enhanced Survival Outcomes with VYLOY™ (zolbetuximab) Combined with Chemotherapy When Common Adverse Events Are Properly Managed

supporting data in the appendix, were later published as a Letter to the Editor in the New England Journal of Medicine in 2024. About the GLOW Phase 3 Clinical Trial GLOW is a Phase 3, global, multi-center, double-blind, randomized study assessing...

FDA Approves New 2-Gram Fibryga® Presentation to Improve Convenience and Precision in Treating Acquired Fibrinogen Deficiency

has long been the standard of care despite its limitations. The expanded product line builds on the success of Fibryga's 2024 FDA approval for AFD, which was supported by the landmark FIBRES study published in JAMA. The study demonstrated that...

FDA Approves Arrowhead Pharmaceuticals’ REDEMPLO® (plozasiran) for Reducing Triglycerides in Adults with Familial Chylomicronemia Syndrome (FCS).

efficacy and safety results from the PALISADE study were presented at the European Society of Cardiology (ESC) Congress 2024 and the American Heart Association Scientific Sessions 2024 (AHA24) and simultaneously published in The New England Journal...

Marius Pharmaceuticals has expanded its global footprint with Health Canada’s approval of KYZATREX® (testosterone undecanoate) CIII capsules

available under a softgel capsule dosage form in Canada. Building on Marius’s earlier submission to Health Canada in July 2024, the company is now poised to provide Canadian men and their healthcare providers with an additional treatment option....

The BioTech Breakthrough Award has been granted to Asahi Kasei for the Planova™ FG1 Filter

Kasei continues to invest in expanding its Planova™ business to meet the growing needs of the biologics market. In May 2024, the company started operation of a new assembly plant for Planova™ filters in Nobeoka City, Miyazaki, Japan, and on...

Gilead’s Livdelzi® Shows Sustained Efficacy in PBC, Reducing ALP, Relieving Itch, and Potentially Slowing Disease Progression

obeticholic acid and 266 used Livdelzi as second-line or monotherapy based on data available since US approval in late 2024. Reductions in alkaline phosphatase (ALP) were observed in both groups, with most patients achieving ALP levels below...

Data on BIMZELX® (bimekizumab-bkzx) in Hidradenitis Suppurativa Showed Sustained Improvements in Pain and Draining Tunnel Resolution for Three Years

system. With approximately 9,000 people in approximately 40 countries, the company generated revenue of €6.1 billion in 2024. UCB is listed on Euronext Brussels (symbol: UCB).

Phase 2 Data of GC Biopharma's Recombinant Anthrax Vaccine, BARYTHRAX, Demonstrates Safety and Immunogenicity, Published in 'Vaccine

vaccines, and is expanding its global presence with successful US market entry of Alyglo™(intravenous immunoglobulin G) in 2024. In line with its mission to meet the demands of future healthcare, GC Biopharma continues to drive innovation by...

Samsung Epis Holdings, Newly Established, to Drive Growth for Samsung Bioepis and Its New Subsidiary

most rapidly advancing biosimilar medicines portfolio, with 11 biosimilars approved and available around the world. In 2024, the company achieved record-breaking sales of KRW 1.5377 trillion and operating profit of KRW 435.4 billion. Samsung...

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