Takeda (TSE:4502/NYSE:TAK) announced today that the FDA has approved ICLUSIG® (ponatinib) through sNDA for treating adults with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. The approval is based on accelerated approval criteria, with confirmation…
SetPoint Medical, a healthcare company focusing on chronic autoimmune diseases, has secured Breakthrough Device Designation from the FDA for its neuroimmune modulation platform aimed at patients with relapsing-remitting multiple sclerosis (RRMS). This designation facilitates interactive communication and priority regulatory review…
908 Devices Inc. (Nasdaq: MASS), known for its portable and desktop devices designed for chemical and biochemical analysis, has announced the adoption of its MX908 device by DrugDetect EU and the NATO Support and Procurement Agency (NSPA). These international contracts…
Fabric Genomics, a pioneer in AI-driven next-generation sequencing interpretation, has announced a fresh collaboration with Intermountain Children’s Health. This partnership aims to analyze whole genomes of children sequenced by Broad Clinical Labs, facilitating faster diagnosis for children suspected of genetic…
Verato, a leading expert in healthcare identity solutions, has announced a collaboration with Google Cloud aimed at empowering healthcare organizations to streamline their operations with a comprehensive enterprise identity data management solution. This partnership addresses the fundamental challenge in healthcare…
LGM Pharma, a prominent provider of customized API and CDMO services throughout the drug product lifecycle, has unveiled major upgrades to its capabilities. This includes a 50% expansion and a substantial investment of over $2 million in its Analytical Testing…
AstraZeneca has initiated a Phase III trial to study the effects of the triple-combination inhaled therapy BREZTRI AEROSPHERE® (budesonide/glycopyrronium/formoterol fumarate, or BGF) on severe cardiopulmonary outcomes in people with chronic obstructive pulmonary disease (COPD). This trial aims to investigate the…
Manifest MedEx (MX), the largest nonprofit qualified health information organization (QHIO) for the CalHHS Data Exchange Framework (DxF), announced today it is securely exchanging permitted health data in real time on behalf of DxF participants, including with other QHIOs, marking…
Janux Therapeutics, a biopharmaceutical company listed on Nasdaq under the symbol JANX, has released its financial results for the fourth quarter and full year of 2023 alongside a comprehensive business update. In 2023, Janux made significant strides in evaluating its…
RenovoRx, Inc. (Nasdaq: RNXT), a clinical-stage biopharmaceutical company dedicated to advancing precision oncology therapies through its local drug-delivery platform, announced today the significant promotions of Leesa Gentry to Chief Clinical Officer and Ronald B. Kocak, CPA to Principal Accounting Officer.…
LEO Pharma A/S, a global leader in medical dermatology, today presented for the first time key results from the DELTA 3 trial of delgocitinib cream, an investigational topical pan-Janus kinase (JAK)-inhibitor, at the 82nd American Academy of Dermatology (AAD) Congress in…
UnitedHealth Group reports significant strides in mitigating the effects of the cyberattack on the U.S. health system and the Change Healthcare infrastructure. Efforts focus on ensuring seamless access to care and medications for consumers and providers impacted by the attack.…