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 ...

Although Secretary Kennedy promised it months ago, a new rule for the Generally Recognized as Safe process is scheduled to be ...

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.

Buying weight-loss drugs online carries risks. Many are unapproved GLP-1 copycats that lack FDA safety testing.

The Tánaiste has rejected claims one committee is “passing the buck” to another about access to a drug that could treat the ...

Rahway-based Merck has secured U.S. Food and Drug Administration approval for a once-daily pill designed to lower artery-clogging cholesterol. Branded as Lipfendra, the drug works by blocking a liver ...

First clinical sites approved and actively screening potential participantsRepresents another major milestone in the advancement of IHL-42X towards Phase III developmentIHL-42X has received FDA Fast ...

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

Joseph Mikhael, MD, MEd, describes the impact of the FDA's approval of subcutaneous isatuximab with an on-body injector device. Joseph Mikhael, MD, MEd, professor in the Applied Cancer Research and ...

Eli Lilly's acquisition of psychedelic drug maker AtaiBeckley extends Big Pharma's embrace of a stigmatized class of ...

The Food and Drug Administration’s Advisory Committee is scheduled to meet on July 29 to review Capricor’s Biologics License ...