BioSpace News Archive

The company’s Truqap, in combination with its endocrine therapy Faslodex, has been approved by the regulator for adult patients with advanced HR-positive breast cancer with specific biomarker alterations.

In this deep dive, BioSpace examines how small, medium and large companies are using artificial intelligence and machine learning to enhance their drug discovery efforts.

When given hours ahead of an expected episode, a late-stage study showed the preventive benefits of Ubrelvy in safely reducing moderate or severe headaches within 24 hours of treatment.

To help cope with the high demand for weight-loss treatments, Eli Lilly is investing $2.5 billion in a German manufacturing facility after last week’s FDA approval of Zepbound for chronic weight management.

Xtandi is now approved to treat nonmetastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis with or without a gonadotropin-releasing hormone analog therapy.

The U.K.’s conditional marketing authorization for Vertex Pharmaceuticals and CRISPR Therapeutics’ gene-edited therapy exa-cel raises some potential safety concerns with the risk of off-target effects.

The company won the third FDA approval in a month for the anti-PD-1 blockbuster, allowing its first-line use in locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

In a 12-1 tally, the FDA’s Pulmonary-Allergy Drugs Advisory Committee determined that the data does not establish a clinically meaningful benefit in this indication.

Verona Pharma plc, announces its President and CEO, David Zaccardelli, has won ‘Executive of the Year 2023’ at the SCRIP Awards in recognition of his exemplary leadership.

PureTech Health plc, a clinical-stage biotherapeutics company, noted that its Founded Entity, Karuna Therapeutics, announced positive results from its Phase 1b open-label, eight-week inpatient trial evaluating the effect of KarXT on 24-hour ambulatory blood pressure in adults with schizophrenia demonstrating that KarXT was not associated with increases in blood pressure.