Airna will use the Series B round to launch a Phase 1/2 trial of its lead program for alpha-1 antitrypsin deficiency, a ...

Marks’ resignation leaves the field without a regulator many view as “integral” to its progress over the last decade.

The drug discovery company, which has partnerships with Eli Lilly and Novartis, is developing AI models to design drugs and ...

Shares in Moderna, Vaxcyte, Novavax and BioNTech all fell Monday after Peter Marks, head of the FDA office that reviews ...

Drugs from Novartis, Amgen and now Lilly have proven powerfully effective at reducing Lp(a). Whether that will translate to a ...

More than one quarter of the medcines cleared by the FDA’s main review office since 2015 have been cancer drugs, a tally that ...

In his resignation letter, Marks cited disagreement with HHS Secretary Robert F. Kennedy Jr., who he said pushed ...

The Sanofi drug, known as fitusiran and now Qfitlia, was approved on Friday for a broad group of people with the rare ...

Pluvicto can now be used before chemotherapy to treat a kind of metastatic prostate cancer, tripling the number of patients ...

The new bid surpasses an offer SK Capital and Carlyle Group made last month for the gene therapy developer, which Bluebird’s ...

Key regulators are not recommending Lilly’s Kisunla be cleared for the European market. The company says it plans to appeal ...