Overdose deaths are falling, but America's illicit drug supply is re-engineering itself into lethal cocktails: fentanyl plus ...

Olanzapine long-acting injectable (LAI) suspension (TEV-'749) has the potential to offer the efficacy of olanzapine in a once-monthly, ...

Feb 20 (Reuters) - The U.S. Food and Drug Administration has approved Vanda Pharmaceuticals' drug for the treatment of two serious mental health conditions, the company said on Friday. The drug, ...

Makary pointed to three bottlenecks: hospital contracting; ethical reviews and approvals; and the Investigational New Drug applications process ...

By Siddhi Mahatole Feb 17 (Reuters) - Disc Medicine said on Tuesday it will pursue a traditional U.S. approval pathway for ...

The US Food and Drug Administration has reversed course and will review a new mRNA flu vaccine from Moderna, the pharmaceutical company said Wednesday, ...

By Mariam Sunny and Michael Erman Feb 18 (Reuters) - Moderna said on Wednesday the U.S. Food and Drug Administration changed course and will review an amended application for its new flu vaccine, a ...

Makary helms the FDA in the midst of a contentious stretch for the agency, defined by massive staff and budget cuts and sweeping changes to vaccine policy.

In a series of high-impact moves, the FDA is reshaping how it approves and regulates drugs, including accelerating reviews, revising vaccine standards and simplifying biosimilar development.

As the U.S. works several levers to lower drug pricing, such as Medicare negotiating costs with drugmakers and President Donald Trump launching TrumpRx, a report from the IQVIA Institute quantified ...