In an ongoing quest to find ways to reduce the cost and time of getting innovative drugs and devices from conception to patients, the Senate Health, Education, Labor and Pensions (HELP) Committee Tuesday asked the FDA and NIH for practical suggestions.

More than a month after approving Sandoz Inc.'s Zarxio as the nation's first biosimilar, the FDA Tuesday issued final versions of the first three draft guidances it released on biosimilars in 2012.

Drugmakers are lining up on both sides of the dance floor as the Federal Circuit prepares to hear arguments June 3 in Amgen Inc. v. Sandoz Inc. – the outcome of which could determine when Sandoz launches Zarxio as the first biosimilar in the U.S.

Exceeding expectations, the success of the breakthrough therapies program has the FDA and patient advocates calling on industry to exercise self-control in requesting the designation, which grants expedited development and review.

With the consequences of the delayed response to the Ebola crisis still fresh on their minds, members of a House subcommittee Wednesday stressed the need to step up U.S. preparedness for bioterrorism attacks.

Reflecting its "current thinking," the FDA released final guidance Tuesday on efficacy endpoints for clinical trials of non-small-cell lung cancer (NSCLC) drugs.

In denying the eighth citizen petition filed by Teva Pharmaceutical Industries Ltd. to protect its blockbuster multiple sclerosis (MS) drug Copaxone from generic competition, the FDA followed a hard and fast regulatory line distinguishing complex nonbiologics from biologics.

While breakthroughs in cancer treatments tend to come in incremental steps, payers in the U.S. cannot continue to pay breakthrough prices for incremental improvements in cancer drugs, two scientists with the National Cancer Institute (NCI) said after finding no rationale for the hefty prices of new cancer drugs.