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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...

Neurocrine Biosciences Launches INGREZZA® SPRINKLE (valbenazine) Capsules.

Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced the launch of a new sprinkle formulation of INGREZZA® (valbenazine) capsules, the #1 prescribed vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of adults with...

AusperBio's AHB-137 Receives Breakthrough Therapy Designation for Chronic Hepatitis B Treatment

AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd. a clinical-stage biotechnology company dedicated to advancing targeted oligonucleotide therapies for achieving functional cure in chronic hepatitis B (CHB) infection, announced that their...

Kedrion Selected by Biotest to Distribute FDA-Approved Immunoglobulin Yimmugo® in the U.S

Kedrion Biopharma Inc. announced that it has established the framework for a long-term agreement with Biotest AG for the full commercialization and distribution of the immunoglobulin therapy Yimmugo® in the U.S., following its Biologic License...

Indivior Publishes New Data Comparing Effectiveness of Intranasal Nalmefene (OPVEE 2.7mg) and IN Naloxone (4mg) in Synthetic Opioid Overdose Model

Indivior PLC announced the publication of a modeling study in Frontiers in Psychiatry that predicts OPVEE (nalmefene) nasal spray (2.7 mg nalmefene, equivalent to 3 mg of nalmefene hydrochloride) resulted in larger reductions in the incidence of...

BioMarin to Present Data Showcasing VOXZOGO® (vosoritide)'s Impact on Bone Health and Quality of Life in Achondroplasia

BioMarin Pharmaceutical Inc. announced the presentation of new data from an investigator-led analysis of the Phase 2 111-205 study, which demonstrate that children with achondroplasia treated with VOXZOGO® experienced increases in bone length...

Qosina Introduces New iDOT™ Single-Use Sensor Bag Ports from Polestar Technologies

Qosina, a global supplier of OEM single-use components to the medical and pharmaceutical industries, has partnered with Polestar Technologies, a leader in optical sensing technologies since 1993, specializing in the monitoring of O2, CO2 and pH....

Agomab Receives FDA Orphan Drug Designation for AGMB-447 in Idiopathic Pulmonary Fibrosis

Agomab Therapeutics NV (‘Agomab’) announced that it has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for AGMB-447, its inhaled, small molecule inhibitor of ALK5. Agomab is evaluating AGMB-447 as a potential...

Lykos Therapeutics Provides Update on FDA Advisory Committee Meeting for Investigational MDMA-Assisted PTSD Therapy

Lykos Therapeutics ("Lykos"), a company dedicated to transforming mental healthcare, announced the outcome of the U.S. Food and Drug Administration's ("FDA") Psychopharmacologic Drugs Advisory Committee ("PDAC"), which discussed the Company's new...

Orthofix Receives FDA 510(k) Clearance for Rodeo™ Telescopic Nail

Orthofix Medical Inc. a leading global spine and orthopedics company, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its Rodeo™ Telescopic Nail. The Rodeo Telescopic Nail is an innovative...

Regulus Therapeutics Progresses to Cohort 4 in Phase 1b MAD Trial of RGLS8429 for ADPKD Treatment

Regulus Therapeutics Inc. a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs today announced, after review of all available safety data, the Company initiated screening of the fourth...

Octapharma USA: FDA Grants Orphan Drug Exclusivity to wilate®

Octapharma USA, Inc. announced the U.S. Food and Drug Administration (FDA) has granted orphan drug exclusivity for wilate®, von Willebrand Factor/Coagulation Factor VIII Complex (Human) Lyophilized Powder for Solution for Intravenous Injection,...

Avenacy announces launch of Eptifibatide for Injection in the U.S.

Avenacy, a specialty pharmaceutical company focused on supplying critical injectable medications, today announced it has launched Eptifibatide for Injection in the United States as a therapeutic equivalent generic for Integrilin® for Injection...

Onconic Therapeutics gets MFDS nod for JAQBO, a fresh remedy for Gastroesophageal Reflux Disease

Onconic Therapeutics, a leading biotechnology company in Korea, announced that the Ministry of Food and Drug Safety (MFDS) of Korea has approved JAQBO (zastaprazan citrate) for the treatment of erosive gastroesophageal reflux disease (GERD) in...

Pyros Pharma announces VIGPODER™ (vigabatrin)

Pyros Pharmaceuticals, Inc. (Pyros or the Company), a leader in the development of enhanced specialty pharmaceuticals for rare diseases, announced that VIGPODER™ (vigabatrin) for oral solution, USP, a treatment for appropriate patients with...

Neurocrine Biosciences begins Phase 1 trial on NBI-1065890, a second-gen VMAT2 inhibitor, in healthy adults

Neurocrine Biosciences, Inc. announced the initiation of its Phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of investigational compound NBI-1065890 in healthy adult participants. NBI-1065890 is...

Translational Vision Science and Technology Journal Publishes RadiusXR's NOVA Clinical Trial

RadiusXR, the trailblazer in Digital Health, announces the publication of its groundbreaking NOVA Clinical Trial in Translational Vision Science and Technology (TVST), a prestigious journal by the Association for Research in Vision and...

Tetra Pharm Technologies advances CB1 antagonist, TPT0701, for appetite suppression into preclinical testing

Following the successful filing of Intellectual Property (IP) for their applied platform technology targeting the endocannabinoid system (ECS), Tetra Pharm Technologies, is moving forward with its compound for appetite suppression, TPT0701....

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