The U.S. FDA issued a complete response letter (CRL) to Telix Pharmaceuticals Ltd. for its NDA for glioma imaging agent, TLX-101-CDx (floretyrosine F18 or 18F-FET, Pixclara), citing the need for additional confirmatory clinical evidence.
The U.S. FDA has granted de novo clearance for Epiminder Pty. Ltd.’s Minder implantable device for continuously monitoring brain activity in patients with epilepsy.
Ascentage Pharma Group Corp. Ltd. said two of its novel candidates have been included in the 2025 Chinese Society of Clinical Oncology Guidelines, including its in-house developed Bcl-2 selective inhibitor, lisaftoclax (APG-2575), which is under review in China and could be the first domestically approved Bcl-2 inhibitor and the second global approval.
China’s National Medical Products Administration (NMPA) has accepted Innocare Pharma Ltd.’s NDA for its second-generation pan-tropomyosin receptor kinase inhibitor, zurletrectinib (ICP-723), for treating adults and adolescents with advanced solid tumors harboring neurotrophic tyrosine receptor kinase gene fusions.
Telix Pharmaceuticals Ltd.’s glioblastoma theranostic, TLX-101, is showing promising overall survival in a phase II trial in recurrent high-grade glioma. The targeted radiation therapy, combined with external beam radiation therapy, demonstrated a median overall survival of 12.4 months from treatment initiation and 32.2 months from initial diagnosis. The results significantly outperform the 9.9-month median survival typically observed with radiation therapy alone in recurrent glioblastoma patients.
China’s National Medical Products Administration has given the thumbs up to Akeso Pharmaceuticals Inc.’s ebdarokimab for treating moderate to severe plaque psoriasis in adults. An interleukin (IL)-12/IL-23 dual-targeted monoclonal antibody, ebdarokimab (also known as AK-101) is the company's first class 1 new drug approved for autoimmune diseases.
Telix Pharmaceuticals Ltd.’s glioblastoma theranostic, TLX-101, is showing promising overall survival in a phase II trial in recurrent high-grade glioma. The targeted radiation therapy, combined with external beam radiation therapy, demonstrated a median overall survival of 12.4 months from treatment initiation and 32.2 months from initial diagnosis. The results significantly outperform the 9.9-month median survival typically observed with radiation therapy alone in recurrent glioblastoma patients.
China’s National Medical Products Administration (NMPA) has accepted Innocare Pharma Ltd.’s NDA for its second-generation pan-tropomyosin receptor kinase inhibitor, zurletrectinib (ICP-723), for treating adults and adolescents with advanced solid tumors harboring neurotrophic tyrosine receptor kinase gene fusions.
The U.S. National Security Commission on Emerging Biotechnology (NSCEB) is urging Congress to reinvest in American biotechnology because “the U.S. is dangerously close to falling behind China,” according to a May 8 report. "The United States is locked in a competition with China that will define the coming century," said NSCEB Chair Senator Todd Young (R-Ind.). “Biotechnology is the next phase in that competition. It is no longer constrained to the realm of scientific achievement. It is now an imperative for national security, economic power and global influence.”
Tryptamine Therapeutics Ltd. is gearing up to enter the clinic with lead compound TRP-8803, an intravenous-infused psilocybin therapy, in patients with binge eating disorder in conjunction with psychotherapy.
