Sanofi has been granted a speedy review from the FDA for a gene therapy for geographic atrophy (GA), a complication of age-related macular degeneration (AMD), as it prepares to test it in a clinical ...

Digital pathology specialist Paige has been awarded breakthrough device status from the FDA for an artificial intelligence tool that can be used to detect cancer across different areas of the body.

Boehringer Ingelheim's bid to return to the oncology arena has been achieved with an FDA approval for Hernexeos, a new, targeted treatment for non-small cell lung cancer (NSCLC). The German pharma ...

Roche's anti-CD20 antibody Gazyva has been on the market for more than a decade as a treatment for blood cancer, but could see a new lease of life if it gets FDA approval to treat kidney disease ...

Astellas has shored up the competitive profile of Izervay as a treatment for eye disorder geographic atrophy (GA), getting FDA approval for an extended treatment duration. The US regulator turned down ...

The much-anticipated pricing agreement between Novo Nordisk and Eli Lilly and the Trump administration on GLP-1 drugs has arrived, with a deal that spans the current injectable products as well as ...

After five years of unprecedented momentum, the ADC field now finds itself at an interesting inflection point. With more programs in development and greater industry prioritization than ever before, ...

The San Diego biotech has filed a lawsuit against the Japanese drugmaker and its US subsidiary, NS Pharma, claiming that the ...

J&J has developed two therapies aimed at the estimated two-thirds of MDD patients who continue to experience symptoms despite ...

Daiichi Sankyo has reported its delayed financial results, saying that high spending on third-party manufacturing and a lower-than-expected take-up of its antibody-drug conjugates for cancer led to a ...

Armed with new phase 3 data, Bayer is preparing to file for approval of a new PET imaging agent that could accelerate the ...

Roche has been working with US AI specialist PathAI for around five years, and has now upgraded that partnership with an offer to buy the company outright for $1.05 billion. Already a giant in the ...