The FDA will select at most five companies that align with national priorities, including lower drug prices and increased ...

The U.S. Food and Drug Administration made the controversial decision to authorize the sale of Juul e-cigarettes, including ...

Oncologic Drugs Advisory Committee (ODAC) voted against the overall benefit/risk profile at the proposed dosage of GSK plc’s ...

In a groundbreaking move, the FDA has approved a new UV light-based process for sanitizing raw milk — one that preserves its ...

Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene ...

The FDA's ODAC voted that the benefit-risk profile of belantamab mafodotin in multiple myeloma were not favorable, ...

ATLAS trial investigator Guy Young, MD, Children's Hospital Los Angeles and University of Southern California Keck School of ...

Sarepta rebuffed a call from the Food and Drug Administration to halt all shipments of its gene therapy for Duchenne muscular ...

At the FDA's request, delandistrogene moxeparvovec (Elevidys), the only approved gene therapy for Duchenne muscular dystrophy ...

Testosterone propionate was once a common treatment for men with low testosterone. It’s a synthetic version of the naturally ...

Aquestive Therapeutics, Inc. (NASDAQ: AQST) ('Aquestive” or the 'Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science ...