Curated news and analysis on clinical trials, drug approvals, and medical research.
ImmunityBio said the FDA accepted its sBLA for ANKTIVA plus BCG in BCG-unresponsive non-muscle invasive bladder cancer with papillary disease. The PDUFA date is Jan. 6, 2027.
Estrogen-only hormone replacement therapy after risk-reducing bilateral oophorectomy was associated with lower breast cancer risk in women with BRCA1 pathogenic variants. In 919 women followed for an average of 8.8 years, incident breast cancer was lower among HRT users than nonusers.
An experimental study found remote ischemic conditioning protected the heart during anthracycline treatment in tumor-bearing mice without reducing antitumor efficacy. The work supports the ongoing RESILIENCE clinical trial in cancer patients.
Cinclus Pharma said its first Phase III study is nearing full enrollment, with topline results expected in the fourth quarter of 2026. The company also reported regulatory progress for linaprazan glurate and a EUR 28 million financing agreement.
The FDA fast-tracked an inhalable gene therapy for advanced lung cancer after an early 11-patient trial showed tumour shrinkage in three patients and disease stabilization in five. Larger studies involving about 250 patients are underway.
Cell and Gene Therapy Catapult has established a Technology Advisory Board to support technology deployment across advanced therapies. The board will focus on data, manufacturing, testing and patient pathways.
Compugen said it will release fourth quarter and full year 2025 results on March 2, 2026, and present at the Needham Virtual Healthcare Conference on April 13. The company also outlined its Phase 1 and Phase 3 immuno-oncology pipeline programs.
Phase 3 BREAKWATER found encorafenib plus cetuximab plus FOLFIRI improved PFS and response in first-line BRAF V600E-mutant metastatic colorectal cancer. OS data remain immature.
Research and Markets added two cell and gene therapy publications, including a tools and reagents market report forecasting growth from $12 billion in 2025 to $19.8 billion by 2030. The reports track approvals, financing, deals, and manufacturing developments.
Century Health raised $5 million in Seed funding led by Origin Ventures. The company plans to expand life sciences partnerships, grow its provider data network, and enhance AI-powered clinical data curation.
Two Louisiana parents published a children’s book to raise awareness of Infantile Neuroaxonal Dystrophy, a rare disorder affecting two of their daughters. They are also helping raise money for a gene therapy trial.
The FDA issued a Complete Response Letter for Disc Medicine’s bitopertin NDA in EPP, saying additional evidence is needed. The agency wants Phase 3 APOLLO data before deciding.
The FDA granted orphan drug designation to AstraZeneca’s surovatamig for follicular lymphoma. The status supports development for rare diseases but is only an early regulatory step.
The CONDOR randomized clinical trial found brolucizumab better preserved visual acuity than panretinal photocoagulation in proliferative diabetic retinopathy at week 54. Brolucizumab also reduced vision-threatening complications and center-involved diabetic macular edema events, while showing more intraocular inflammation.
Russian lawmakers submitted a bill allowing use of patented drugs in research before patent expiry to prepare generic registration. The measure mirrors a Bolar exemption as patent disputes over early generic launches rise.
A phase I trial and a preclinical study found viral immunotherapy triggered T cell responses in glioblastoma. The clinical study enrolled 41 patients; the mouse study showed prolonged survival and immunologic memory.
A study from the University of Osaka identified the integrin αV–YAP–CTGF pathway linking chronic liver congestion to fibrosis. The findings point to a potential therapeutic target in congestion-related liver disease.
The FDA granted Orphan Drug Designation to Cullinan Therapeutics’ CLN-049 for relapsed/refractory AML. CLN-049 is in Phase 1 studies and had already received Fast Track designation.
The pharmaceutical packaging equipment market is projected to grow from US$6.1 billion in 2024 to US$12.6 billion by 2034. The pharma blister packaging machines market is valued at USD 3.04 billion in 2025 and is forecast to reach USD 4.13 billion by 2035.
OKYO Pharma said it expanded its Scientific Advisory Board with the appointment of Marta Sacchetti as urcosimod advances in neuropathic corneal pain. The company said urcosimod has Fast Track designation and earlier received a single-patient expanded access IND.
