Pharma & Biotech - Page 14

Jiangsu Hengrui Pharma and Elevar Therapeutics have seen their hopes for a first-line liver cancer combination approval dashed by two separate FDA citations. The FDA issued complete response letters targeting the combination

Claire Knapp, the chief executive of Havas Lynx UK, is expanding her remit to take on oversight of the agency’s New York operation as part of a significant leadership overhaul. Knapp, who

Sarepta Therapeutics has appointed Michael Severino as its next chief executive officer, effective July 28, the rare disease drugmaker announced on Monday. Severino will succeed Doug Ingram, who announced plans to retire

Gilead Sciences has unveiled a new HIV prevention campaign called “Up to Date,” targeting Black adults who are sexually active, with a particular focus on women. The campaign aims to encourage people

Outlook Therapeutics has secured FDA approval for Lytenava, a reformulated ophthalmic version of Roche’s widely used cancer and eye treatment bevacizumab, after three prior rejections. The New Jersey-based company received the greenlight

The strain on patient access across the United States is intensifying, with rural communities bearing the heaviest burden of a healthcare system under significant financial pressure. More than 200 rural hospitals have

Otsuka’s Simtriyo has received FDA approval as a once-daily extended-release capsule for treating ADHD in adults and children aged six and older weighing at least 20 kg. The drug, known generically as

Arrowhead Pharmaceuticals has released compelling data from two phase 3 clinical trials, positioning the company as a serious contender in the severe hypertriglyceridemia treatment space. The results come less than a month

Summit Therapeutics has released updated overall survival data from its phase 3 HARMONi trial as the FDA moves toward a landmark decision on ivonescimab. The new analysis, based on a data cut-off

Samsung Biologics (KRX: 207940) has announced plans to acquire Swiss peptide manufacturer PolyPeptide in a deal worth approximately $1.8 billion, marking a landmark moment for South Korean biopharma. The transaction is described