The approval follows the CHMP's reversal of a previous decision not to recommend the drug, instead recommending it with certain restrictions.

In an increasingly crowded space, the firm is using streamlined manufacturing and lipid nanoparticle delivery for its in vivo ...

In a new study, Picture Health's QVT score identified responders and non-responders to immunotherapy and chemoimmunotherapy.

The approval includes patients whose disease progressed after treatment with endocrine therapy, which can cause ESR1 mutations.

The firm commenced a $200 million underwritten public offering, secured $125 million in non-dilutive funding, and refinanced $50 million in debt.

Patients on Enhertu and Perjeta lived more than three years without disease progression compared to just over two years on Perjeta, Herceptin, and chemo.

Researchers still see potential for the TIL therapy to benefit patients if combined with other immunotherapies, like checkpoint inhibitors.

The firm has licensed Solid's AAV-SLB101 capsid and plans to fund preclinical development with a potential $1.1 million investment from the Jain Foundation.

The company submitted data showing A400's efficacy in patients with advanced RET fusion-positive NSCLC in first- or later-line treatment.

The firm's lead candidate, EN-374 for X-linked chronic granulomatous disease, is being evaluated in a Phase I/II trial.

Advanced ER-positive breast cancer patients on giredestrant and Afinitor had better progression-free survival versus standard therapy in the evERA trial.

Regulators in the UK also approved the IDH1/2 inhibitor last week, making it the first precision targeted treatment in Europe for this post-surgery setting.