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ImmPACT Bio announces FDA clearance of its IND application for CD19/CD20 bispecific CAR-T cell therapy in multiple sclerosis

ImmPACT Bio USA Inc.a clinical-stage biopharmaceutical company developing a new generation of cellular therapies that have the potential to bring transformational benefits to patients, announced the United States Food and Drug Administration (FDA)...

Gilead’s Livdelzi (Seladelpar) receives FDA accelerated approval for primary biliary cholangitis

Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Livdelzi® (seladelpar) for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in...

Aptar’s Nasal Unidose System will deliver neffy® (epinephrine nasal spray), the first FDA-approved needle-free treatment for Type I allergic reactions, including anaphylaxis

AptarGroup, Inc. a global leader in drug and consumer product dosing, dispensing and protection technologies, announced that its Unidose Liquid System (Unidose) is the delivery system approved with neffy® (epinephrine nasal spray), the first and...

Derm-Biome Pharmaceuticals to develop skincare treatment that promotes skin health and longevity

Derm-Biome Pharmaceuticals Inc, a Vancouver-based biopharmaceutical company focused on skin health and healthy aging, is excited to announce the development of a novel, science-backed skincare treatment aimed at targeting some of the root causes...

Spencer Trask & Co. launches Signal12 for Dry Eye Disease treatment, led by former Aerie executives, advancing Pro-ocular through trials

Spencer Trask & Co. the advanced technology development firm, announced today the launch of Signal12 Inc. (Signal12), a clinical-stage dry eye company. Signal12 is revolutionizing treatments for Dry Eye Disease (DED) and eliminating the hassle of...

Persist AI and Nivagen partner to develop AI-driven manufacturing for long-acting injectables

Persist AI and Nivagen have announced a collaboration to co-develop a next-generation manufacturing process for long-acting injectable (LAI) drugs, using Persist's AI-based formulation technology and Nivagen's manufacturing capabilities. The...

Citius Pharmaceuticals' LYMPHIR™ wins FDA approval for relapsed/refractory cutaneous T-cell lymphoma

Citius Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved LYMPHIR™ (denileukin diftitox-cxdl), a novel immunotherapy for the treatment of r/r cutaneous T-cell lymphoma (CTCL) after at least one prior...

Axion BioSystems extends its agreement with Corning®, granting exclusive rights to distribute its award-winning cell counting device.

Axion BioSystems announced an agreement with Corning Incorporated that continues Corning’s exclusive worldwide distribution rights for the Corning® Cell Counter. The simple yet powerful device, developed by Axion BioSystems and distributed by...

Formosa licenses Clobetasol Propionate Ophthalmic Suspension to Apotex for ocular surgery relief

Taiwan-based Formosa Pharmaceuticals announced that the company has entered into an exclusive licensing agreement with Apotex Inc. ("Apotex"), for exclusive rights in Canada to the commercialization of clobetasol propionate ophthalmic suspension,...

Sensitech acquires Berlinger & Co. to expand life sciences cold chain solutions

Carrier Global Corporation, on behalf of its Sensitech business, a world leader in supply chain visibility, has completed its acquisition of the Monitoring Solutions business of Berlinger & Co. AG, a Swiss family-owned company that specializes in...

Jade Biosciences launches with $80 million to develop transformative autoimmune disease therapies

Jade Biosciences, Inc. a biotechnology company dedicated to developing best-in-class therapies for patients living with autoimmune diseases, announced the closing of an $80 million financing. The financing was led by Fairmount and Venrock...

Eximia Research Network expands into Virginia by integrating Tidewater Clinical Research

Eximia Research announces the integration of Tidewater Clinical Research into its national network of clinical trial sites. This strategic development unites Tidewater's longstanding expertise in Women's Health and Ophthalmology with Eximia's...

Inoviv launches MasterKey™, a customizable platform for multiplexed protein assays

Inoviv announces the launch of MasterKey™, which enables researchers to select specific proteins from a comprehensive, pre-characterized catalog of thousands of proteins. This database is built from years of extensive research, utilizing technical...

Lipella Pharmaceuticals initiates Phase 2a trial for LP-310 in oral lichen planus, enrolling the first patients

Lipella Pharmaceuticals Inc. a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today announced the enrollment of the first patients in its multi-center Phase 2a clinical trial evaluating LP-310 for the...

NewAmsterdam Pharma announces positive topline data from the Phase 3 BROOKLYN trial of Obicetrapib in heterozygous familial hypercholesterolemia patients

NewAmsterdam Pharma Company N.V a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”). For whom...

BerGenBio selects 2nd dose in Phase 2a STK11m Non-Small Cell Lung Cancer trial.

BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, announced that the independent Data and Safety Monitoring Board (DSMB) for BerGenBio's Phase...

Innocan Pharma submits Investigational New Animal Drug application to FDA's Veterinary Center.

Innocan Pharma Corporation a pioneer in the pharmaceutical and biotechnology industries, is pleased to announce that the FDA's Center for Veterinary Medicine (CVM) has granted the Company a sponsor fee waiver and assigned an Investigational New...

Teva and Sanofi Announce Accelerated Anti-TL1A Phase 2b Program for Inflammatory Bowel Disease

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. and Sanofi announced an update to the timing for the anti-TL1A, duvakitug (formerly known as TEV-’574/SAR447189) program investigating the human IgG1-λ2 monoclonal...

Transposon announces Phase 2 results for TPN-101 in treating C9orf72-related ALS and frontotemporal dementia

Transposon Therapeutics, a biotechnology company developing a platform of novel, orally administered therapies for the treatment of neurodegenerative and aging-related diseases, including Alzheimer's disease, announced final results from its Phase...

Prolacta Bioscience Leads in Human Milk Science, Regularly Reviewing Health Claims with FDA

Prolacta Bioscience®, the world's leading hospital provider of 100% human milk-based nutritional products, takes its obligation to the critically ill and premature infants it serves, and to the doctors providing them with care, extremely...