After a lengthy regulatory back-and-forth, Eisai and Biogen's Alzheimer's drug is on the market in Europe. Elsewhere, Sandoz is alleging Amgen's patent actions were anticompetitive.

The biotech is developing an experimental drug for the most common of a family of disorders all caused by errors in ...

While J&J expects tariffs will cost it $400 million this year, the company maintained its earnings estimate and upped its ...

Camzyos’ failure in a form of hypertrophic cardiomyopathy dampened its commercial outlook and spurred debate as to whether ...

The Commerce Department has begun a so-called Section 232 investigation into the national security effects of the U.S.

Signs of potential liver damage in a study participant led the company to abandon danuglipron, a drug it hoped would help it ...

The Atlas-backed company plans to liquidate its assets, including an experimental drug for chronic spontaneous urticaria it ...

As first quarter earnings begin, executives are confronting market turmoil, regulatory instability and the threat of U.S.

Wall Street analysts said the results for Verve’s therapy appeared competitive on efficacy, while avoiding any major safety ...

Using integrated lab, claims, and EMR data, the manufacturer can pull in test results and deploy NLP on the unstructured EMR ...

This blog delves into the rise of rare disease drug approvals and the critical importance of regulatory guidance in shaping ...

The initiative, which will start with monoclonal antibodies, is the first big regulatory shift from the FDA since Martin ...