CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SHANGHAI, May 8, 2026 /PRNewswire/ -- Harbour BioMed (the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology, oncology and other disease areas, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for HBM7004, enabling the initiation of a first-in-human (FIH) Phase I clinical trial. The

GOTHENBURG, Sweden, May 8, 2026 /PRNewswire/ -- The recruitment represents a significant strategic addition to the company as it continues the development of its innovative drug platform within pain and inflammatory diseases. Dr. Lundberg has had a long and highly successful international career spanning both academia and the global pharmaceutical industry. He began his career as a researcher and professor at the Karolinska Institute and established himself at a very early stage as one of the wo

Even strong data underperform when HCPs aren't prepared and convinced on launch day, ZoomRx said. Cancer treatments with high levels of physician awareness at launch maintain their advantage over drugs that are yet to gain widespread recognition when they come to market, a ZoomRx analysis found. ZoomRx, which provides launch-tracking services, analyzed 44 brands across more than 10 cancer indications. The company divided the drugs into four categories based on brand penetration

RMAT designation based on promising Phase 1b/2a clinical data, including safety profile and preliminary response rates, with trans-splicing ribozyme-based RNA editing platform SEOUL, South Korea, May 8, 2026 /PRNewswire/ -- Rznomics a biopharmaceutical company specializing in RNA-based gene therapeutics, announced today that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) Designation to RZ-001, its lead investigational candidate for the treat

→ It didn’t take long for Natalie Holles to rebound after the decision to wind down operations at her previous company. She has replaced Elisabet de los Pinos as CEO of Aura Biosciences , which is investigating belzupacap sarotalocan (or bel-sar ) in early choroidal melanoma. Aura indicated that it wanted to enroll 100 patients for the Phase 3 CoMpass study, and the Boston biotech says it has signed up 86 patients so far. Holles ran Audentes Therapeutics after it was purchased by Astellas and su

BARCELONA, Spain, May 8, 2026 /PRNewswire/ -- Angel Yeast (SH600298), the world's leading manufacturer of yeast and yeast protein, has participated in Vitafoods Europe 2026, the premier global nutrition and health exhibition, on May 5–7 at the Fira de Barcelona. The company highlights its patented technology breakthrough AngeoPro Yeast Protein, alongside a comprehensive portfolio of functional ingredients designed to address global challenges in sustainable nutrition, sports performance, and hol

Capricor Therapeutics said Thursday it has filed a lawsuit against Nippon Shinyaku over a distribution and commercialization agreement for deramiocel, a cell therapy candidate for Duchenne muscular dystrophy (DMD) that’s getting a second chance at US approval. Capricor is seeking to terminate the agreement entirely, and its lawsuit makes two key claims against Nippon and its US subsidiary, known as NS Pharma. The first claim is that “a fundamental pricing flaw” in the agreement means it would be

STOCKHOLM, May 8, 2026 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that the U.S. Food and Drug Administration (FDA) has extended the review period by three months for the supplemental Biologics License Application (sBLA) for a once weekly lecanemab irmb subcutaneous injection, also known as Leqembi® Iqlik™, as a starting dose for the treatment of early Alzheimer's disease. The new Prescription Drug User Fee Act (PDUFA) action date is August 24

TOKYO and CAMBRIDGE, Mass., May 8, 2026 /PRNewswire/ -- Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period by three months for the supplemental Biologics License Application (sBLA) for a once‑weekly lecanemab‑irmb subcutaneous injection (U.S. brand name: LEQEMBI® IQLIK™) as a starting dose for the treatment of early Alzheimer's disease. The new Prescription Drug User Fee Act (PDUFA) action date is August

Gilead Sciences' stock yo-yoed during after-hours trade Thursday after it revealed that $11.5-billion in anticipated charges related to its M&A spree will likely affect full-year earnings. Instead of an $8.45 to $8.85 per-share profit, as previously projected, the company is now guiding for an adjusted loss of $1.05 to $0.65 a share for 2026. The biopharma made upfront payments of $1.675 billion and $3.15 billion, respectively, to buy Ouro Medicines and Tubulis, while its deal to acquire cell th