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Samsung Bioepis and Organon’s HADLIMA™ Gains FDA Interchangeability Designation, Expanding Access to Adalimumab Alternative

Samsung Bioepis Co., Ltd. and Organon & Co. announced that the US Food and Drug Administration (FDA) has designated the HADLIMA™ (adalimumab-bwwd) high- and low-concentration (40 mg/0.4 mL, 40 mg/0.8 mL) autoinjectors and high-concentration...

Fresenius Kabi Introduces Epinephrine Injection, USP, in 30 mg/30 mL Multi-Dose Vials

Fresenius Kabi, an operating company of Fresenius, announced today that Epinephrine Injection, USP, is now available in the United States in 30 mg per 30 mL multi-dose vials. Epinephrine Injection 30 mg per 30 mL is a prescription medicine used...

Otulfi® (ustekinumab-aauz) by Fresenius Kabi Now FDA-Approved as an Interchangeable Biosimilar

Fresenius Kabi, an operating company of Fresenius, and Formycon AG, announced that the U.S. Food and Drug Administration (FDA) designated Otulfi® (ustekinumab-aauz) as an interchangeable biosimilar to the reference product Stelara® (ustekinumab)....

Research from Noster finds that a gut bacteria-derived molecule can shrink fat cells and improve metabolism

Joint study by University of Shizuoka, Kobe University, and Noster Inc. uncovers a novel postbiotic pathway for obesity prevention.A new collaborative study from the University of Shizuoka, Kobe University, and Kyoto-based biotech company Noster...

Kimera® Labs named a semifinalist in the $101 million XPRIZE Healthspan competition for pioneering innovations in healthy aging

Kimera Labs, Inc., the pioneer in therapeutic exosome biotechnology, is proud to announce its selection as a semifinalist in the prestigious $101 million XPRIZE Healthspan competition. This milestone recognizes Kimera's groundbreaking work in...

Rein Therapeutics announces the initiation of the RENEW Phase 2 trial of LTI-03 in patients with IPF

Rein Therapeutics a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, announced that the RENEW Phase 2 trial of its lead asset,...

Viralgen Partners with Trogenix to Advance AAV Gene Therapy for Glioblastoma

Viralgen, a leading contract development and manufacturing organization (CDMO) specializing in recombinant adeno-associated virus (rAAV) gene therapies, has established a strategic collaboration with Trogenix, a pioneering biotech company...

PCI Pharma Buys Ajinomoto Althea as Part of $1B Plan to Expand Injectable Drug Manufacturing in the U.S

PCI Pharma Services (“PCI”) – a leading global contract development and manufacturing organization (CDMO) focused on innovative biopharma therapies – has completed its acquisition of Ajinomoto Althea, Inc. (“Althea”), a US-based sterile...

Xencor Announces Promising Early Results for XmAb942 in First-in-Human Study Targeting IBD

Xencor, Inc.a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and autoimmune diseases, today announced positive interim results from its first-in-human study of XmAb942. A high-potency,...

Optune Lua® by Novocure Receives CE Mark Approval for Treating Metastatic Non-Small Cell Lung Cancer

Novocure announced that Optune Lua® has received a CE (Conformité Européenne) Mark for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) concurrently with immune checkpoint inhibitors or docetaxel who have...

BioClear Toenail Fungus Device Under Review: Effective LED Laser for Healthy Nails & Discoloration Treatment

Toenail fungus, medically known as onychomycosis, is more than just a cosmetic issue. It's a persistent condition that affects the appearance, health, and comfort of your feet. What begins as a small yellow or white spot under the nail can...

ENHERTU® Plus Pertuzumab Significantly Improves Progression-Free Survival vs. THP in 1st-Line Treatment for HER2+ Metastatic Breast Cancer

Positive high-level results from a planned interim analysis of the DESTINY-Breast09 Phase III trial showed ENHERTU® (fam-trastuzumab deruxtecan-nxki) in combination with pertuzumab demonstrated a highly statistically significant and clinically...

Paragonix Celebrates a Major Milestone: 100 Kidney Transplants Powered by the FDA-Cleared KidneyVault™ System

Paragonix Technologies, a leader in organ transplant technologies and services, today announced the successful completion of its hundredth case using the FDA-cleared KidneyVault™ Portable Renal Perfusion System. This milestone was achieved with...

JelloX Biotech Establishes U.S. Research Base

JelloX Biotech Inc., a Taiwan-based startup at the forefront of cancer pathology, is announcing it will open a lab in the Discovery Oasis biotechnology space in Phoenix, Arizona. An expansive 120-acre development, Discovery Oasis is envisioned as...

AdvanCell Proudly Announces $18M in MRFF Frontiers Initiative Funding to Advance Targeted Alpha Therapy for Defeating Prostate Cancer

AdvanCell, a clinical-stage radiopharmaceutical company developing innovative cancer therapeutics, announced $18M in Australian Federal Government Funding from the Medical Research Future Fund (MRFF) Frontiers Initiative for ‘Defeating Prostate...

Glenmark Pharmaceuticals Launches Vancomycin Hydrochloride for Injection in the U.S

Glenmark Pharmaceuticals Inc., USA (Glenmark) announces the launch1 of Vancomycin Hydrochloride for Injection USP, 750 mg/vial, 1.25 g/vial and 1.5 g/vial (Single-dose vial). Glenmark's Vancomycin Hydrochloride for Injection USP, 750 mg/vial, 1.25...

PeptiGrowth Inc. Launches Novel Synthetic KGF Alternative Peptide (FGFR2b Agonist)

PeptiGrowth Inc. (Headquarters: Chiyoda-ku, Tokyo, President: Junichiro Ishizuka) has successfully developed a novel synthetic peptide called "KGF alternative- peptide (FGFR2b agonist)" which is functionally equivalent to recombinant keratinocyte...

Developing innovative production technology for the commercialization of 3D cell products, PHC and Cyfuse collaborate

PHC Corporation a subsidiary of PHC Holdings Corporation (Headquarters: Chiyoda-ku, Tokyo; President: Kyoko Deguchi), and Cyfuse Biomedical K.K. announce the successful development of a new production technology(*1) for the commercialization of...

Marking a new era of uncovering the potential of NAD+ with precision science, ChromaDex evolves into Niagen Bioscience

Niagen Bioscience, Inc. the global authority on NAD+ (nicotinamide adenine dinucleotide) with a focus on the science of healthy aging, today confirmed it has changed its corporate name to Niagen Bioscience, Inc. (“Niagen Bioscience” or the...

At AAD 2025, five-year data for BIMZELX® (bimekizumab-bkzx) demonstrated sustained skin clearance and long-term efficacy in moderate-to-severe plaque psoriasis

UCB, a global biopharmaceutical company, announced further long-term data from the Phase 3 trials, and their open-label extensions, investigating BIMZELX® (bimekizumab-bkzx) in adults with moderate-to-severe plaque psoriasis (PSO). Dual inhibition...