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LOTUS study data on DAYBUE® (trofinetide) for Rett Syndrome's long-term efficacy and tolerability is published in Developmental Medicine and Child Neurology

Acadia Pharmaceuticals Inc. announced that the journal Developmental Medicine and Child Neurology published interim results from the caregiver-reported observational online, open-label, ongoing LOTUS study evaluating effectiveness and tolerability...

At World Sleep 2025, Avadel Pharmaceuticals will present new data on LUMRYZ™ (sodium oxybate) for extended-release oral suspension

Avadel Pharmaceuticals plc a biopharmaceutical company focused on transforming medicines to transform lives, today announced that new data supporting the use of LUMRYZ as a narcolepsy treatment will be presented in one oral presentation and 16...

Nuvation Bio unveils new data on IBTROZI™ (taletrectinib) in advanced ROS1-positive non-small cell lung cancer

Nuvation Bio Inc. a global oncology company focused on tackling some of the toughest challenges in cancer treatment, announced new and updated results from the pivotal Phase 2 TRUST-I and TRUST-II studies evaluating IBTROZI™ (taletrectinib) for...

In Afghanistan, WHO and UNICEF will launch a polio vaccination campaign utilizing the PharmaJet® Tropis® ID delivery system

PharmaJet®, a company that strives to improve the performance and outcomes of injectables with its enabling needle-free injection technology, announced that the WHO prequalified Tropis ID delivery system will be used to support a polio eradication...

Izalontamab Brengitecan Receives FDA Breakthrough Therapy Designation for Advanced EGFR-Mutated NSCLC

SystImmune Inc. (SystImmune), a clinical-stage biotechnology company, and Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has granted. Breakthrough Therapy Designation (BTD) to izalontamab brengitecan (iza-bren) for...

Viatris announces the approval of the first generic iron sucrose injection in the U.S

Viatris Inc. a global healthcare company, announced the U.S. Food and Drug Administration (FDA) has approved Iron Sucrose Injection, USP, an intravenous iron replacement product used to treat iron deficiency anemia (IDA) in adult and pediatric...

Roche's first respiratory test, powered by TAGS technology, has received FDA clearance for SARS-CoV-2, Influenza A, Influenza B, and RSV

Roche announced the U.S. Food and Drug Administration (FDA) 510(k) clearance for the cobas® Respiratory 4-flex. This is the first FDA-cleared assay utilizing Roche's innovative TAGS (Temperature-Activated Generation of Signal) technology, designed...

BD Announces the First Pharma-Sponsored Clinical Trial Using BD Libertas™ Wearable Injector Technology for Biologic Drugs

BD (Becton, Dickinson and Company) a leading global medical technology company, announces the first pharma-sponsored combination product clinical trial using the BD Libertas™ Wearable Injector for subcutaneous delivery of complex biologics. The...

Sun Pharma Announces the Launch of LEQSELVI™ (deuruxolitinib) in the United States for Treating Severe Alopecia Areata

Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715 (together with its subsidiaries and/or affiliated companies, "Sun Pharma") announced LEQSELVI™ (deuruxolitinib) 8 mg tablets is now available...

Nuvation Bio’s IBTROZI™ (taletrectinib), a next-generation oral treatment for advanced ROS1-positive non-small cell lung cancer, has been approved by the U.S. Food and Drug Administration

Nuvation Bio Inc. a global oncology company focused on tackling some of the toughest challenges in cancer treatment, announced that the U.S. Food and Drug Administration (FDA) has approved IBTROZI™ (taletrectinib) for the treatment of adult...

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)....

SK Life Science Labs Announces Nature Communications Publication of Breakthrough Molecular Glue Research Advancing Cancer Immunotherapy

SK Life Science Labs, a subsidiary of SK Biopharmaceuticals Co., Ltd., a global biotech focused on the research, development, and commercialization of treatments for cancer and disorders of the central nervous system (CNS), announced the...

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...

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...

Exicure, Inc. (Nasdaq: XCUR) Unveils Next Steps Toward New Clinical Trial in Acute Myeloid Leukemia (AML)

Exicure, Inc. today shared updates on its lead asset, GPC-100 (burixafor), a small molecule CXCR4 inhibitor. Exicure, Inc. (“Exicure”) is planning for a clinical trial in Acute Myeloid Leukemia (AML) with GPC-100. The company believes that...

Biologic Therapy Improves Pregnancy Outcomes in High-Risk Antiphospholipid Syndrome Patients, Says HSS

A landmark clinical trial co-led by Hospital for Special Surgery (HSS) has found that blocking inflammation with the drug certolizumab significantly reduces the risk of serious adverse pregnancy outcomes in women with antiphospholipid syndrome...

Fresenius Kabi Launches Calcitonin Salmon Injection, USP Synthetic

Fresenius Kabi, an operating company of Fresenius, announced today it has introduced Calcitonin Salmon Injection, USP Synthetic, a calcium regulator, for the treatment of symptomatic Paget’s disease of the bone and hypercalcemia. The drug is also...

ADC Therapeutics shares promising initial LOTIS-7 trial data on ZYNLONTA® combined with a bispecific antibody for relapsed/refractory DLBCL.

ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), announced positive initial data from the LOTIS-7 Phase 1b open-label clinical trial evaluating the safety and efficacy...

Neurophet gains FDA 510(k) clearance for Neurophet AQUA, advancing multiple sclerosis analysis with AI-driven precision

Neurophet, an artificial intelligence (AI) solution company for brain disease, announced on the "Neurophet AQUA", has obtained 510(k) clearance from U.S. Food and Drug Administration (FDA) for its newly integrated multiple sclerosis (MS) analysis...

Cure51 selects 10x Genomics Visium HD to drive its new drug discovery initiative

French TechBio startup Cure51 and 10x Genomics, Inc., a leader in single cell and spatial biology, announced that Cure51 will deploy 10x Genomics' Visium HD as part of its pioneering work to understand the unique biology of exceptional cancer...

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