The European Commission will now consider the committee's positive opinions as it determines whether to grant marketing authorization to the drugs.
NEW YORK – Create Medicines has started clinically testing an in vivo CAR therapy that comprises a cancer-killing medley of T, NK, and myeloid cells.
The firm said the CHMP would not support the application due to concerns about the control arm used in the Phase III PSMAfore trial.
Four of nine patients responded to the mesothelin-directed therapy, which uses a multi-chain receptor borrowed from NK cells, ...
Regeneron's Otarmeni is the first gene therapy approved for OTOF-related hearing loss, which the firm said it will provide to ...
Company execs still have high hopes for the SERD giredestrant, despite a recent trial failure in first-line metastatic breast ...
The firm is hoping to show that ODM-212 has anti-tumor activity and can prevent treatment resistance across multiple cancer indications.
Researchers at AACR described the development of a classifier that identified a proportion of tumor samples with HRD that did not have BRCA1/2 mutations.
The firm closed an oversubscribed Series B financing round to fund a pivotal trial of RTx-015 and advance a clinical trial in ...