The agency previously declined to approve Atara's first Ebvallo biologics license application, but has accepted a data package it resubmitted this month.

The impact of Tagrisso plus chemo on overall survival in a Phase III trial has boosted the firms' confidence to parry competitors.

As Keytruda generic competition looms larger on the horizon, the company is hoping to reinvest the savings into pipeline growth drivers.

The firm will retain rights to its preclinical assets including two T-cell receptor T-cell therapies and its allogenic program.

Neurologists from multiple clinics shared data at AAIC on the Alzheimer's drug's use, shedding light on its safety and ...

The FDA investigated the death of a boy in Brazil on Elevidys and concluded it was unrelated to the treatment.

The FDA investigated the death of a boy in Brazil on Elevidys and concluded it was unrelated to the treatment.

NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended regulators approve Servier's IDH1/2 inhibitor Voranigo (vorasidenib) as a treatment for ...

Trontinemab is a formulation of Roche's failed gantenerumab but now paired with the company's Brainshuttle technology to ...

The Medicines and Healthcare Products Regulatory Agency said it will closely track adverse events associated with the treatment.

The therapies, which are just starting to enter clinical trials, will need to prove clear clinical and quality-of-life ...