The FDA's New Drug Regulatory Program (NDRP) within the Center for Drug Evaluation and Research (CDER) has undergone substantial modernization efforts since its launch in 2017. Aimed at enhancing the efficiency and effectiveness of CDER processes in light of advances in genetic science,
Recent clinical advancements by PolTREG, a pioneering Polish biotechnology company, have cast a hopeful light on the treatment of type-1 diabetes (T1D). The company's breakthrough Treg therapy, PTG-007, has shown great promise in fundamentally altering the management of this autoimmune
Biopharmaceuticals are in a critical transition phase where the mission to provide high-quality, effective drugs is increasingly converging with the demand for environmentally sustainable production methods. This balance requires the adoption of innovative technologies under the Industry 5.0
The field of cell therapy, initially heralded as a revolutionary frontier in biotechnology, is now grappling with considerable hurdles that threaten its progress and market penetration. Known for pioneering treatments like CAR-T cell therapy, which modifies a patient's T-cells to combat cancer
Spur Therapeutics, previously known as Freeline Therapeutics, is making waves in the field of genetic medicine with its rebranding and renewed mission to revolutionize the treatment of chronic diseases through gene therapy. The company's ambitious initiatives encompass innovative research,
Advancements in cancer treatments have always been a focal point in medical research. Mustang Bio, Inc. (Nasdaq: MBIO) has recently made significant strides in the battle against Waldenstrom macroglobulinemia (WM), a rare type of blood cancer. Their latest clinical trial results for MB-106, a
In a bold move that underscores its commitment to oncology and global expansion, Japan-based Ono Pharmaceutical Co., Ltd. has finalized its acquisition of Deciphera Pharmaceuticals Inc., a U.S. biopharmaceutical firm specializing in cancer treatments. The transaction was settled with the purchase
The landscape of medical treatment and drug development is experiencing a new dawn as the U.S. Food and Drug Administration (FDA) plays a pivotal role in ushering in an era where the once unimaginable becomes reality. With a discerning eye on cutting-edge therapies, especially in gene therapy and
In the rapidly advancing field of nuclear radiation therapy, a groundbreaking treatment is emerging, promising to redefine the landscape of medical response to nuclear events. Financed by the backing of a weighty $4.2 million agreement with the National Institute of Allergy and Infectious Diseases
In the fast-evolving landscape of biopharmaceuticals, innovative approaches to drug discovery signal a transformative era for companies like Hoth Therapeutics Inc. A strategic partnership with Wise Systems International SRL marks the beginning of an ambitious journey to incorporate artificial
