Westfield Health Bulletin: new FDA approval plan doesn’t prioritize safety

Here in the USA, we have lived with the confidence that the medications sold over the counter, by prescription or ...

Trump Administration Eases Approval Process for Biosimilar Drugs

The Trump administration is proposing changes to Food and Drug Administration guidelines that would make it less expensive ...
GlobalData on MSN

FDA looks to simplify biosimilar development with new draft guidance

The draft guidance, which is touted as a way to reduce the cost and time-associated burden of biosimilar development, has ...
JD Supra

New FDA approval process promotes development of rare disease gene therapies

The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by ...

FDA announces plans to relax rules about copycat drugs

The U.S. Food and Drug Administration announced it will relax certain rules for approving low-cost versions of some ...

Eli Lilly says weight-loss pill a candidate for speedy approval under new US program

Eli Lilly said on Thursday its experimental weight-loss pill met most criteria for the U.S. Food and Drug Administration's ...

How the FDA plans on fast-tracking leucovorin to treat autism

The FDA enlisted British drugmaker GSK to help it fast-track approval of leucovorin to treat an autism-related disorder.

Investor pressure may be driving risky AI medical device launches

AI is transforming health care, but a new study from researchers at Johns Hopkins, Georgetown, and Yale suggests we might be ...