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

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

-- 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

The Trial Exceeded Target Overall Response Rate (ORR) of 20%, with 44% Response Rate Among Patients with Acute Myeloid Leukemia-Myelodysplasia-Related Changes (AML MR) Treated at Optimal Dose of 30 mg Twice a Week (BIW) and 50% in AML MR with Myelomonocytic/Myelomonoblastic (M4/M5) Subtype Median Overall Survival (mOS) of 8.9 Months in Patients with AML MR and 8.8 mOS in Relapsed or Refractory to Venetoclax-Based Regimens at 30 mg BIW Dose Level Surpasses the Historical Benchmark of 2.4 Months F

FDA issued Complete Response Letter Capricor plans to resubmit its BLA to include data from the ongoing Phase 3 HOPE-3 trial in Q3 2025 to continue pursuing the indication for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy FDA advised Capricor to request a meeting to determine next steps toward potential approval Conference call and webcast scheduled for today at 8:30 a.m. ET July 11, 2025 -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing t

July 11, 2025 -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering allogeneic, off-the-shelf invariant natural killer T (iNKT) cell therapies, today announced the publication of another landmark case in Nature’s Oncogene describing a complete and durable remission in a patient with metastatic, treatment-refractory testicular cancer, following treatment with agenT-797, MiNK’s allogeneic iNKT cell therapy. Complete remission after failure on platinum-b