A week into his tenure as head of the FDA’s Center for Drug Evaluation and Research, experts agree that Rick Pazdur is the ...

Drugs approved by the FDA’s expanding program to expedite reviews for products in line with the Trump administration’s agenda ...

The Food and Drug Administration awarded the drug’s sponsor, biotech company Revolution Medicines, a new and unconventional ...

FDA Section 524B transformed medical device cybersecurity from guidance to law, challenging small medtech firms with ...

US regulators laid out new guidelines for approving custom-made treatments for individual patients, a move that could bring ...

At the end of September, President Trump invited Pfizer CEO Albert Bourla to the Oval Office to announce that the company and the administration had reached a "deal" on most-favoured nations drug ...

The question for business leaders is not if this opportunity is real, but who will define the standards for it.

Pfizer and Novo Nordisk continue to fight for ownership of obesity startup Metsera; CDER Director George Tidmarsh leaves his ...

Lumia is ready to release its health-tracking smart earrings to the masses.

Following the FDA approval of a vagus nerve stimulator for rheumatoid arthritis, supporters of the device’s use have lauded ...

Trailing Twelve-Month Core Product Sales -- $37 million, a company record, up from $33.8 million, with distributor and ...

Learn about the impact of genetics and environment on Type 2 diabetes. Dr. Griffin P. Rodgers shares insights and advice for ...