In response to the 21st Century Cures Act, the FDA outlined its regulatory approach in guidance documents about software as a medical device.
The once-a-week shot for people with Type 2 diabetes reduces blood sugar levels and can also reduce appetite.
The Senate health committee will get its first crack at assessing the Trump administration's implementation of last year's key bipartisan healthcare law.
The monthly injection has the potential to reduce dangerous relapses that occur when patients stop taking the currently available daily medication. But that benefit has not yet been shown in studies and the new drug comes with a hefty price: $1,580 per monthly dose.
The FDA's new guidance aims to make it easier for generic firms to plan how they can copy complex drugs like epinephrine auto-injectors, which should ultimately lower pharmaceutical prices.
The FDA is drafting guidance that it hopes will lead to more medication-assisted treatments for opioid abuse. But doctors are unsure if the effort will work.
Chip Davis, the president and CEO of the Association for Accessible Medicines, talks about the need for more competition to bring down healthcare costs.
Kite Pharma's newly approved blood cancer treatment, Yescarta, uses gene therapy techniques not to fix disease-causing genes but to turbocharge T cells, immune system soldiers that cancer can often evade.
The Food and Drug Administration is opening a new front in its efforts to reduce high drug prices by encouraging development of generic versions of hard-to-make medicines.
The agency notified 74 manufacturers of so-called immediate-release opioids that their drugs will now be subject to the tougher requirements, although doctors would not be compelled to take part in the training.
Rural hospitals have long wanted to be part of the so-called 340B program, too, but were blocked from participating until the Affordable Care Act . But, unlike bigger hospitals, rural hospitals can't get discounts on expensive drugs that treat rare diseases.
The Food and Drug Administration will host a meeting Monday to discuss changes to the approval process of new drugs. The agency is under immense pressure to speed up the approval of new drugs while also ensuring they are safe.