Key Takeaways On April 1, 2026, FDA issued a statement reminding 503A pharmacies and 503B outsourcing facilities that ...

The US Food and Drug Administration (FDA) and the generic drug industry have reached agreement on some areas amid ...

The US Food and Drug Administration (FDA) announced it is unifying its various adverse reporting systems into a single system called the Adverse Event Monitoring System (AEMS). The agency said the ...

The Food and Drug Administration issued a warning letter to Novo Nordisk — the maker of Ozempic and Wegovy — for failing to report potential side effects in patients who took its blockbuster ...

A raw cheese producer has declined to issue a recall of two of its products after the Food and Drug Administration linked the cheeses to a multistate outbreak of a dangerous strain of E. coli.

The agency estimates the change could shave $20 million from the cost of developing a new biosimilar drug. The FDA published draft guidance on its website Monday outlining the changes. The policy is ...

Runway is launching a $10 million fund and startup program to back companies building with its AI video models, as it pushes ...

The Food and Drug Administration (FDA) recently added the Association for the Advancement of Medical Instrumentation's primary guidance document on cybersecurity for artificial intelligence (AI) or ...

The FDA has launched a new adverse event reporting system that will consolidate several systems it has for reporting different types of adverse events, the agency announced Wednesday. The new system, ...

The reference architecture connects enterprise and public scientific data to accelerate target identification and compound ...

Protein supplements that are found to contain significantly less protein than the amounts stated on their labels could face serious legal action, including possible classification as "counterfeit food ...