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Archive by category Global Health & Biotech

U.S. FDA approves JASCAYD® (nerandomilast) tablets for the treatment of progressive pulmonary fibrosis in adults

Not intended for UK audiences Progressive pulmonary fibrosis (PPF) is a life-threatening, progressive lung condition, causing a continuous decline in lung function.1,2 Affecting up to 100,000 people in the U.S. and up to 5.6 million worldwide, PPF is linked to an underlying clinical interstitial lung disease (ILD) diagnosis, such as autoimmune ILD or hypersensitivity pneumonitis.3,4,5 [...]

Alvotech and Teva Secure U.S. Settlement Date for AVT06, a Proposed Biosimilar to Eylea®

According to the settlement agreement, the proposed biosimilar to Eylea® (aflibercept) can be marketed in the U.S., if approved by the FDA, in the fourth quarter of 2026, or earlier under certain circumstances REYKJAVIK, Iceland and TEL AVIV, Israel, Dec. 19, 2025 (Korea Bizwire) – Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development [...]

Philips agrees to acquire SpectraWAVE Inc., advancing next-generation coronary intravascular imaging and physiological assessment with AI

December 15, 2025 Acquisition of SpectraWAVE’s next-generation technologies including HyperVueTM Imaging System with Enhanced Vascular Imaging for comprehensive, rapid, and AI-supported imaging inside the coronary arteries, and X1TM-FFR, an AI-enabled angio-based FFR technology that delivers rapid, accurate coronary physiology assessment from a single angiogram [1] SpectraWAVE’s technologies have the potential to significantly increase adoption of coronary [...]

Accelerating Patient Recruitment and Research Excellence: TrialWire® Supports Endpoints Clinical Trials Day NYC 2025

NEW YORK, Dec. 12, 2025 (Korea Bizwire) – TrialWire®, the industry’s fastest, intelligent patient recruitment engine breaking the bottleneck in clinical development, proudly supported Endpoints News’ 2025 Clinical Trials Day in New York City. The event gathered leaders from across the biopharma ecosystem to discuss the evolution of clinical research and how technology continues to improve patient access and [...]

Teva Releases Q4 2025 Aide Memoire

TEL AVIV, Israel, Dec. 12, 2025 (Korea Bizwire) – Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today that its Q4 2025 Aide Memoire is available on the “Investors” page on its website. Q4 2025 Aide Memoire Teva has compiled this document with public information that was previously provided by Teva in order to assist [...]

Teva to Host Conference Call to Discuss Fourth Quarter 2025 Financial Results at 8 a.m. ET on January 28, 2026

TEL AVIV, Israel, Dec. 12, 2025 (Korea Bizwire) – Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today that it will issue a press release on its fourth quarter 2025 financial results on Wednesday, January 28, 2026, at 7:00 a.m. ET. Following the release, Teva will conduct a conference call and live webcast on [...]

Crinetics Announces First Patient Dosed in Pivotal Adult Trial of Atumelnant in Congenital Adrenal Hyperplasia (CAH)

Phase 3 study builds on positive phase 2 results showing rapid and sustained reductions in key disease biomarkers and clinical measures of CAH SAN DIEGO, Dec. 11, 2025 (Korea Bizwire) – Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced that the first patient has been dosed in the CALM-CAH Phase 3 trial evaluating investigational candidate atumelnant, a novel, [...]

Io Therapeutics, Inc., presents today at the San Antonio Breast Cancer Symposium preclinical studies demonstrating effectiveness of IRX4204, the company’s clinical stage retinoid X nuclear receptor (RXR) agonist compound, for synerg

SPRING, Texas, Dec. 11, 2025 (Korea Bizwire) – Io Therapeutics, Inc., a privately held pharmaceutical company headquartered in Spring, Texas; announced today presentation at the San Antonio Breast Cancer Symposium, in San Antonio, TX; of data from preclinical studies demonstrating effectiveness of IRX4204, the company’s phase II clinical stage retinoid X nuclear receptor (RXR) agonist [...]

Impulse Dynamics Completes $158M Financing Round

Investment to Fuel Strategic Growth and Future Product Commercialization Marlton, NJ, Dec. 10, 2025 (Korea Bizwire) – Impulse Dynamics®, a global medical device company committed to improving the lives of people with heart failure (HF), announced today that it raised more than $158 million in financing to enhance commercialization and fuel both the clinical and [...]

JASCAYD® (nerandomilast) receives first regulatory approval for progressive pulmonary fibrosis in China

The approval marks the first new treatment option for people living with progressive pulmonary fibrosis (PPF) in more than five years. PPF is a rare lung condition, more life-threatening than many forms of cancer, causing a continuous decline in lung function.1,2,3 PPF is the second approved indication in China for nerandomilast, following recent approvals in [...]