The U.S. FDA released the latest version of its premarket cybersecurity guidance regarding medical devices, replacing the 2025 edition and offering recommendations on implementing measures for preventing digital attacks or authorized access.
Prelude Therapeutics Inc. has received IND clearance from the FDA for PRT-12396, a mutant-selective JAK2 V617F inhibitor being developed for the treatment of patients with certain myeloproliferative neoplasms.
Elevar Therapeutics Inc. appointed Kim Dong-gun (DG) as CEO Jan. 29, as the company focuses on post-NDA strategies for lirafugratinib in bile duct cancer, and the twice-rejected rivoceranib-camrelizumab combination for liver cancer.
Sciwind Biosciences Co. Ltd. said Jan. 30 it won Chinese approval for self-developed glucagon-like peptide-1 (GLP-1) receptor agonist, ecnoglutide (Xianyida), to treat adults with type 2 diabetes.
For years, Japan’s “drug lag” was shorthand for slow regulatory reviews and delayed approvals compared with the U.S. and Europe. But even as regulatory timelines have shortened, review capacity has expanded and international alignment has improved, Japanese patients still face gaps in access to innovative drugs.
At a recent Cabinet meeting, U.S. Health and Human Services (HHS) Secretary Robert Kennedy reportedly said he expected Trumprx to probably go live within 10 days. That was Jan. 29, two days before HHS was once again forced to shut down many of its activities due to a congressional gridlock over a fiscal 2026 appropriations package to keep the department and several others open beyond Jan. 30.
ABL Bio Inc. has submitted an IND application to the FDA seeking clearance to begin a phase I trial of ABL-209 (NEOK-002). Pending approval, the trial is expected to begin by mid-year in the U.S.
Onchilles Pharma Inc. has obtained IND approval from the FDA for N-17350, enabling initiation of first-in-human studies in patients with advanced solid tumors. The study will enroll patients in the U.S. and Australia with advanced solid tumors.
The U.S. FDA is now accepting requests from biopharma companies to participate in its new Precheck pilot program, which is intended to make it faster and easier for companies to relocate their prescription drug manufacturing to the U.S.
Sciwind Biosciences Co. Ltd. said Jan. 30 it won Chinese approval for self-developed glucagon-like peptide-1 (GLP-1) receptor agonist, ecnoglutide (Xianyida), to treat adults with type 2 diabetes.
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-CEO-Elevar-1-30.webp?height=488&t=1769801176&width=650 "Kim Dong-gun (DG), CEO, Elevar")
