The FDA's push for lower-cost medicines looks good on paper, but the patent office under President Trump may be going in the ...

In announcing his new Commissioner's National Priority Voucher (CNPV) program, FDA Commissioner Marty Makary, MD, MPH, described it as "a common-sense approach" intended "to bring more cures and ...

The US Food and Drug Administration will take steps to streamline the development of generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to accelerate ...

Ed Silverman, a senior writer and Pharmalot columnist at STAT, has been covering the pharmaceutical industry for nearly three decades. He is also the author of the morning Pharmalittle newsletter and ...

With a Trump-driven reduction of nearly 2,000 employees, agency officials view artificial intelligence as a way to speed drugs to the market. By Christina Jewett The Food and Drug Administration is ...

The FDA granted Priority Review to the supplemental New Drug Application (sNDA) for lurbinectedin in combination with atezolizumab as a first-line maintenance treatment for patients with ...

The agency announced moves to cut regulatory obstacles for the makers of biosimilar drugs, which are akin to generics and may help lower drug costs. By Rebecca Robbins The Food and Drug Administration ...

WASHINGTON, D.C. — The U.S. Food and Drug Administration announced two major actions last week: making its internal drug application checklists public to improve transparency and issuing the ...

The templated letter sent across industry reiterates many of the same concerns highlighted in the press release and serves as notice of FDA’s enforcement approach to all drug application holders, ...

WASHINGTON (AP) — The head of the Food and Drug Administration’s drug center abruptly resigned Sunday after federal officials began reviewing “serious concerns about his personal conduct,” according ...