Biodexa Pharmaceuticals PLC (“Biodexa” or “the Company”), (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, announced the filing of a Clinical Trial Application (CTA) with the European Medicines Agency (EMA) for its Serenta trial in patients with familial adenomatous polyposis (FAP), a mostly inherited disease that, if left untreated, almost always leads to colorectal cancer. The only cu

In June 2025, several breakthrough drugs received their first global approvals and market launches, marking significant advances in therapeutic innovation. 1. Genakumab (Firsekibart) Firsekibart (Genakumab), developed by Changchun Genescience Pharmaceutical, is a fully human monoclonal antibody targeting interleukin-1β (IL-1β). It functions as an IL-1β inhibitor and was approved in China on June 30, 2025, for the treatment of gouty arthritis, especially in patients who are intolerant or unresp

In May 2025, a new wave of capital and technological resonance swept across the global biotechnology sector. Industry giants such as CSPC Pharmaceutical Group, Sanofi, and Eli Lilly accelerated their deployment of next-generation therapies through multibillion-dollar deals. From AI-driven targeted protein degradation (TPD) and RNA editing to in vivo CAR-T therapies, and from oral small-molecule drugs to non-opioid analgesics, the industry is fiercely competing around three central themes: “conqu

July 14, 2025 -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialisation of novel therapies for rare and ultra-rare genetic diseases, today announced that Health Canada has extended the approval of Evkeeza® (evinacumab) as an adjunct to diet and other low-density lipoprotein cholesterol (LDL-C) lowering therapies to treat children aged 6-months and older with homozygous familial hypercholesterolemia (HoFH). Evkeeza, an angiopo

Collaboration focuses on the discovery of novel, non-CRBN/VHL, Targeted Glue™ degraders for oncology and immunology indications 16 July 2025 – Amphista Therapeutics (“the Company” or “Amphista”), a leader in the discovery of next-generation, Targeted Protein Degradation (TPD) medicines, today announces the successful achievement of a discovery research milestone under its exclusive research collaboration and licence agreement with Merck. In conjunction with the milestone achievement, Amphista r

July 15, 2025 -- Piston Bio LLC, a biotechnology company developing both small molecules and biologics for the treatment of cancer, today announced that its scientific advisors have endorsed the potential of its next-generation therapeutic designed to induce tumor surface antigens and prevent immune escape. The endorsement follows a scientific advisory board meeting convened last month to review nonclinical data. Meeting attendees were Antoni Ribas, MD, PhD, Professor of Medicine and Director,

July 15, 2025 -- Medera Inc. ("Medera"), a clinical-stage biopharmaceutical company focused on targeting cardiovascular diseases by developing next-generation therapeutics, and its clinical development division Sardocor, together with the University of Kansas Medical Center, today announced the successful treatment of the first patient in the MUSIC-DMD Phase 1b clinical trial. The trial is investigating AAV1.SERCA2a, a one-time gene therapy treatment for cardiomyopathy secondary to Duchenne mus

PolyPid's proprietary and clinically validated, prolonged-release drug delivery technology aims to subcutaneously deliver GLP-1 for approximately 60 days, compared to current standard of care of weekly injections. The GLP-1 delivery platform expands PolyPid's product portfolio beyond the recently successful Phase 3 D-PLEX100, demonstrating versatility of the Company's proprietary drug delivery platforms in multiple major therapeutic areas. July 15, 2025 -- PolyPid Ltd. (Nasdaq: PYPD) ("PolyPid

-- Topline results from the CHASE trial expected by end of Q3 2025 -- -- Potential for CHASE to serve as a pivotal trial in support of a Biologics License Application (BLA) submission, contingent on positive results -- July 09, 2025 -- KALA BIO, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare and severe diseases of the eye, today announced the completion of patient enrollment in the CHAS

Outcome of Regenerative Medicine Advanced Therapy (RMAT) meeting provides clear regulatory pathway to approval in a continuous Phase 1 / 2 / 3 study, avoiding the requirement for an additional registrational study and accelerating time to potential approval Expansion builds on favorable efficacy and safety data from Part A of the LIGHTHOUSE study Enrollment of pivotal cohort expected to begin in Q1 2026; BLA submission anticipated in early 2028 ATSN-201 on track to potentially be the first gene