PursueCare Launches FDA-Authorized RESET® and RESET-O® for Addiction Treatment
PursueCare, a leader in virtual addiction treatment, has announced the launch of RESET® and RESET-O®, the first FDA-authorized prescription digital therapeutics for substance use disorder (SUD) and opioid use disorder (OUD). These innovative app-based therapies offer a self-guided 12-week cognitive…
Acadia Pharmaceuticals Gets Health Canada Approval for DAYBUE™ in Rett Syndrome
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) has announced that Health Canada has granted marketing authorization for DAYBUE™ (trofinetide) to treat Rett syndrome in patients aged two and older. This approval, under the Priority Review process, makes DAYBUE the first and only…
bit.bio Secures Landmark Patent Defense for opti-ox™ Cell Programming Technology
bit.bio, a leader in synthetic biology focused on coding human cells for innovative therapies, has successfully defended its foundational European patent for opti-ox. This groundbreaking technology allows for the deterministic forward programming of pluripotent stem cells (PSCs), including induced pluripotent…
Celltrion Reveals Two-Year Post-Hoc Analysis Results for Subcutaneous Infliximab (CT-P13 SC) in IBD Treatment
Celltrion has announced the two-year results of dose escalation therapy with subcutaneous infliximab (CT-P13 SC) at the United European Gastroenterology (UEG) Week 2024 in Vienna. A post-hoc analysis of the LIBERTY-CD (Crohn’s disease) and LIBERTY-UC (ulcerative colitis) studies indicates that…
FDA Approves Novocure’s Optune Lua® for Metastatic Non-Small Cell Lung Cancer
Novocure (NASDAQ: NVCR) has announced that the U.S. Food and Drug Administration (FDA) has approved Optune Lua® for use alongside PD-1/PD-L1 inhibitors or docetaxel. This treatment is intended for adult patients with metastatic non-small cell lung cancer (mNSCLC) who have…
Simple Blood Test Can Predict Future Heart Attacks and Cardiac Events
Siemens Healthineers has announced a new prognostic claim for its Atellica IM High-Sensitivity Troponin I (TnIH) test, significantly enhancing care for at-risk cardiac patients in the U.S. This straightforward blood test allows healthcare providers to identify patients at risk of…
Airway Therapeutics Launches Phase 3 Study of Zelpultide Alfa for Preterm Infants at Risk of BPD
Airway Therapeutics, Inc. has announced the launch of a multinational Phase 3 clinical trial for zelpultide alfa (rhSP-D). This study aims to prevent bronchopulmonary dysplasia (BPD) and mitigate lung injury in premature infants. The biopharmaceutical company focuses on developing innovative…
Invisalign® Palatal Expander Now Available in Hong Kong for Dental Growth
Align Technology, Inc. (Nasdaq: ALGN), a global leader in medical devices known for its Invisalign® clear aligners, iTero™ intraoral scanners, and exocad™ CAD/CAM software, has announced the launch of its Invisalign Palatal Expander System in Hong Kong. This system is…
MEDiC Life Sciences Secures $5M Investment from LG and Hanmi for Cancer Biomarker Technology
MEDiC Life Sciences, a prominent functional genomics startup in Silicon Valley, has announced a $5M strategic investment from LG and Hanmi Pharmaceutical. This funding precedes MEDiC’s upcoming Series-A round later this year. Previously, the company raised $8M in a Seed…
FDA Clears SPECTRALIS Flex Module for Enhanced Ophthalmic Imaging Access
Heidelberg Engineering, a leader in ophthalmic imaging and healthcare data solutions, has announced FDA clearance for the SPECTRALIS® Flex Module. This innovative multimodal platform is specifically designed for diagnostic imaging of the posterior segment in both pediatric and adult patients…
MEDiC Life Sciences Partners with Hanmi Pharmaceutical on Cancer Biomarker Discovery
MEDiC Life Sciences, a Silicon Valley biotech startup, has announced a research collaboration with Hanmi Pharmaceutical, a prominent biopharma company based in Korea. Through this partnership, MEDiC will utilize its MCAT™ platform to identify cancer biomarkers related to one of…
Exelixis and Merck Collaborate on Zanzalintinib Trials for Cancer
Exelixis, Inc. (Nasdaq: EXEL) and Merck (NYSE: MRK), known as MSD outside the U.S. and Canada, have announced a clinical development collaboration. The partnership will evaluate the investigational tyrosine kinase inhibitor (TKI) zanzalintinib in combination with Merck’s anti-PD-1 therapy KEYTRUDA®…