TAIPEI, Aug. 28, 2025 /PRNewswire/ -- Foresee Pharmaceuticals (6576.TWO), ("Foresee") announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for CAMCEVI ETM (leuprolide mesylate 21 mg, ready-to-use long-acting injectable (LAI) formulation administered every 3 months), as a treatment for advanced prostate cancer. "The approval of CAMCEVI ETM (21 mg) is a significant step toward our mission in improving the standard of care and the lives of pat

Financial Results and Operational Update for the Full Year Ended June 30, 2025NEW YORK, Aug. 28, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (ASX:MSB; Nasdaq:MESO), global leader in allogeneic cellular medicines for inflammatory diseases, today provided financial results and an operational update for the period ended June 30, 2025. Mesoblast Chief Executive Dr. Silviu Itescu said, “This has been a banner year for the Company, with achievement of FDA approval for Ryoncil®, the first and only FD

Second quarter (April-June 2025) Operating loss amounted to SEK -2,892,341 (-5,841,409). Loss for the period amounted to SEK -2,732,070 (-5,622,779). Cash flow from operating activities totaled SEK -5,991,211 (-7,733,270). Earnings per share before and after dilution totaled SEK -0.06 (-0.16). Period (April-June 2025) Operating loss amounted to SEK -10,961,745 (-11,274,831). Loss for the period amounted to SEK -10,745,532 (-10,992,456). Cash flow from operating activities totaled SEK -6,736,135

– Bempedoic Acid Receives Strongest Endorsement from ESC/EAS Guidelines Based on Compelling and Practice-Changing Evidence – – Guideline Recognition of ‘Strike Early and Strike Strong’ Approach with Early Combination Lipid-Lowering Therapy Affirms Continued Development of Company’s Oral Triple Combination Therapies in U.S. – ANN ARBOR, Mich., Aug. 29, 2025 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today welcomed the inclusion of bempedoic acid as the only non-statin newly recommended for LDL-C

LEQEMBI IQLIK is the first and only anti-amyloid treatment to offer an at-home injection to help patients and care partners continue to treat this progressive, relentless disease after initial treatment of 18 months LEQEMBI IQLIK will be launched on October 6, 2025, in the U.S. TOKYO and CAMBRIDGE, Mass., Aug. 29, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Headquarters: Cambridge, Massachusetts, CEO: Christopher A. Vie

Flickr /DHS/Tia Dufour Health Secretary Robert F. Kennedy Jr. will testify before the Senate Finance Committee on Sept. 4, following the ouster of CDC Director Susan Monarez and tapping of HHS Deputy Secretary Jim O’Neill as her interim replacement. Health Secretary Robert F. Kennedy Jr. will again face U.S. Senators amid the current upheaval at the highest levels of CDC leadership. News of Kennedy’s Senate testimony was broken by Politico on Thursday, citing two anonymous sources who added t

iStock, SiyueSteuber Nipocalimab, approved as Imaavy for generalized myasthenia gravis earlier this year, failed to show significantly added benefit when used with an anti-TNFα therapy in patients with rheumatoid arthritis. Johnson & Johnson’s FcRn blocker nipocalimab showed no significant therapeutic benefit in a mid-stage rheumatoid arthritis trial, pushing the pharma to discontinue its development. J&J was testing nipocalimab plus an anti-TNFα therapy in the Phase IIa DAISY trial, enrollin

Created with Canva Dreamlab †, iStock During the COVID-19 pandemic, Health Secretary Robert F. Kennedy Jr.—along with FDA Commissioner Marty Makary and CBER Director Vinay Prasad—argued against vaccine mandates, partly because they limited medical choice. This week, the FDA under their leadership approved updated COVID-19 vaccines with restrictions that do the same. On Monday, I saw an outlandish story published in The Daily Beast . According to one source, the Trump administration could be p

Pfizer and BioNTech’s supplemental Biologics License Application (sBLA) has been approved by the US Food and Drug Administration (FDA) for its LP.8.1-adapted monovalent COVID-19 vaccine (COMIRNATY LP.8.1; COVID-19 Vaccine, mRNA) for use in adults aged 65 years and older, as well as in adults 64 years and younger and children from the age of five who have at least one underlying condition that makes them high risk for severe outcomes from COVID-19. The FDA approval is based on the cumulative body

Stockholm, August 29, 2025 – Immedica is pleased to announce the publication of favorable long-term data on Loargys (pegzilarginase), demonstrating sustained clinical benefits including clinically significant improvements in mobility and spasticity in patients 2 years and older with Arginase 1 deficiency (ARG1-D). ARG1-D is an autosomal recessive urea cycle disorder (UCD) characterized by chronic hyperargininemia, leading to progressive spasticity, developmental delay, and seizures. Current stan