Michelle Tarver will officially replace longtime CDRH leader Jeff Shuren, who stepped down from the role earlier this year.

A medicine the pharma acquired in a $430 million buyout of Visterra in 2018 succeeded in a Phase 3 trial in IgA nephropathy, a crowded corner of drug research.

The activist investor claims Pfizer failed to capitalize on the windfall earned from its COVID-19 vaccine and, in the process, destroyed tens of billions of dollars in market value.

The gene editing company will focus on “in vivo” medicines, while seeking to license out or find a development partner for its clinical-stage treatment reni-cel.

Sapio Sciences' mission is to improve lives by accelerating discovery, and because science is complex, Sapio makes technology simple. Sapio is a global business offering an all-in-one science-awareTM ...

Early study data from Wave Life Sciences suggests how editing RNA may yield viable medicines. Large and small drugmakers say such results are just the start.

Immunotherapy and precision medicine show promise in better fighting cancer. What else does the research tell us?

BP’s program includes a novel PSMA-binding molecule that may be a potential next-generation radioligand therapy (RLT) for prostate cancer and is currently being studied in two investigator-initiated ...

Under the proposed deal, the PE firm would take a controlling 50% stake in Sanofi’s Opella unit, with state-owned Bpifrance taking a minority 2% position.

Shares in the Boston-based biotech creator, which had a standout success in forming Karuna Therapeutics, trade around cash levels — a "huge value disconnect" its leaders are trying to bridge.

The medicine, which Novo sells as Rybelsus, cut the risk of cardiovascular complications by 14% when added to standard therapies in people with diabetes and heart disease.

Vyalev’s clearance is the second victory for AbbVie in Parkinson’s this year, following an April readout for a drug acquired through its Cerevel buyout.