FDA Establishes First MSC Quality Control Protocol
January 26, 2026 | 11:44
American regulators introduced pioneering quality standards for mesenchymal stromal cells, establishing manufacturing and testing benchmarks that could accelerate therapeutic development in regenerative medicine.
D3 Bio Gains FDA Clearance for Two Trials
January 19, 2026 | 11:55
The biotechnology company secured regulatory approval to advance two investigational drug studies, including a phase one trial and a combination therapy study, marking progress in its oncology pipeline.
GenEditBio gets FDA clearance for in vivo genome editing programme
January 06, 2026 | 11:37
The clearance allows human trials for its one-time treatment targeting a genetic eye disease that causes vision loss.
Kazia eyes early FDA talks on brain cancer survival edge
October 28, 2025 | 15:26
Company seeks Type C meeting to fast-track NDA for paxalisib after GBM patients live months longer.
Angel Yeast Wins GRAS Nod, Plans U.S. Protein Tsunami
September 05, 2025 | 15:40
FDA green-light turns microbe-grown nutrients into meat-free burgers and energy bars, eyeing 30% price slash versus pea isolates.
Celltrion secures FDA nod for STEQEYMA® pediatric dosing
June 16, 2025 | 13:00
The approval of a new presentation enhances treatment flexibility for children with inflammatory diseases.
XellSmart gains FDA clearance for three iPSC cell therapies
June 03, 2025 | 15:00
New hope emerges for Parkinson’s, spinal injury, and ALS with cutting-edge tech.
FDA Greenlights IND for NTS071, Nutshell Therapeutics’ Cancer Drug
May 05, 2025 | 10:00
New p53 reactivator targets rare Y220C mutation with breakthrough potential.
FDA Approves Akeso’s Penpulimab for Dual Use in Nasopharyngeal Cancer Treatment
April 25, 2025 | 11:47
A major clinical win positions Penpulimab-kcqx as a new standard in advanced cancer care.
FDA Approves Minder®, the First Implantable Continuous EEG Monitor in the US
April 23, 2025 | 09:00
A breakthrough in brain health monitoring, Minder® opens new frontiers in long-term, real-time EEG tracking.
FDA Approves New Prostate Cancer Imaging Agent Gozellix®
March 21, 2025 | 07:38
Telix Pharmaceuticals Limited today announces that the United States Food and Drug Administration has approved its New Drug Application for Gozellix® gozetotide injection), Telix's next-generation PSMA-PET imaging agent for prostate cancer.
FDA Grants Orphan Drug Designation to MicuRx's MRX-5 for NTM Infections
January 02, 2025 | 11:52
Shanghai MicuRx Pharmaceutical Co., Ltd. announced that MRX-5, its self-developed anti-infection drug.
RiboX therapeutics announces FDA clearance for IND application of RXRG001
October 26, 2024 | 00:24
RiboX Therapeutics Ltd, a pioneering biopharmaceutical company, focused on discovering and developing fully engineered circular RNA therapeutics, announced that the US Food and Drug Administration has cleared its IND application for the Phase I/IIa Study of RXRG001 on October 25 th, 2024.
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