Brian Sullivan, CEO of Plymouth-based Celcuity, is convinced his biotech startup will soon provide the new standard of care for tens of thousands of breast cancer patients. Last week, Celcuity won ...

Marty Makary resigned as FDA commissioner amid controversy. But his reforms to drug review times and AI are the agency's ...

As the agency considers seven unapproved peptides, Michael A. Sekeres traces the origins of the FDA’s authority.

First clinical sites approved and actively screening potential participantsRepresents another major milestone in the advancement of IHL-42X ...

There's good news to report when it comes to women's health. A new study provides encouraging evidence that most clinical ...

Company requested Type B pre-IND meeting with U.S. FDA to discuss development and regulatory strategy for its investigational tetravalent T-cell engager, HCW11-018b Company has developed a streamlined ...

In an interview, Carl H. June discusses how CAR-T therapy transformed blood cancer treatment, the challenges of extending it ...

The U.S. has signed a nuclear cooperation agreement with Saudi Arabia. And, the independent autopsy results of Nolan Wells ...

Samsung Biologics has been on a steep upward growth trajectory since receiving its first licence to produce biologic drug substances in 2015.

Fortress Biotech is trading below its cash balance, offering deep value relative to its assets and financial improvements.

Danish healthcare company Novo Nordisk in partnership with Celonis, the global leader in Process Intelligence, is speeding up ...

The FDA’s acceptance of the daraxonrasib NDA is an important step in the regulatory review process and brings us closer to the possibility of offering patients a new targeted medicine for previously ...