The European Commission will now consider the committee's positive opinions as it determines whether to grant marketing authorization to the drugs.

The firm said the CHMP would not support the application due to concerns about the control arm used in the Phase III PSMAfore trial.

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 ...

Four of nine patients responded to the mesothelin-directed therapy, which uses a multi-chain receptor borrowed from NK cells, ...

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.

Maze intends to use the net proceeds to advance its lead candidates, kidney disease treatments that mimic the protective effects of genetic variants.

The firm is hoping to show that ODM-212 has anti-tumor activity and can prevent treatment resistance across multiple cancer indications.

Kyverna is hoping to nab FDA approval for the first treatment for SPS and the first CAR T-cell therapy for an autoimmune ...

The firm closed an oversubscribed Series B financing round to fund a pivotal trial of RTx-015 and advance a clinical trial in ...

Regulators reviewed data from the Phase II FIREFLY-1 trial, in which the overall response rate was 53 percent, according to a scale for low-grade gliomas.

The organizations are betting they can develop a redosable genetic therapy for LMNA-related congenital muscular dystrophy that could be a cure.