The biotech is planning to expand antisense oligonucleotide capabilities and infrastructure on campuses that already produce ...

The path to market for Roche’s astegolimab became more uncertain after the investigational antibody failed to significantly ...

Otsuka and Lundbeck’s data are insufficient to establish significant efficacy of Rexulti plus sertraline in PTSD, according ...

Roche and Genentech were unable to sufficiently demonstrate the benefit of using Columvi in an earlier treatment setting for ...

In light of recent patient deaths, the FDA has also revoked its platform designation for Sarepta’s AAVrh74 technology. The ...

Amid a season of regulatory and scientific advances, experts reveal a culture of data hoarding among cell and gene therapy ...

Earlier this summer the FDA asked Moderna for more efficacy data on its flu vaccine before it could review an mRNA-based ...

The patient, who was being treated with an investigational gene therapy for limb-girdle muscular dystrophy, died of acute ...

In its Q2 earnings call Thursday, Novartis said it is moving quickly to reshore its drug manufacturing operations, but CEO ...

The panelists flagged safety concerns with Blenrep and GSK’s failure to optimize its dosing regimen for the antibody-drug ...

Following the death of two teenage patients with Duchenne muscular dystrophy following Elevidys treatment, Sarepta ...

The molecule, developed in collaboration with Massachusetts-based Kailera Therapeutics, is headed for a new drug application ...