In August last year, the Health Department cut around $500 million in mRNA research funding, with Health Secretary Robert F.

Without naming a specific product, Commissioner Marty Makary referred to an investigational therapy, delivered surgically ...

President Trump called Commissioner Marty Makary to the White House to discuss his frustration with the agency handling of ...

For more than a decade, CAR-T therapy has been the miracle of oncology, turning end-stage blood cancers into curable diseases ...

Where FDA breakthrough devices stand through 2025: growth, authorizations, leading specialties, AI trends, and qualification pathways explained.

Explore FDA's QMSR and cybersecurity mandates for medical devices, including SPDF, SBOMs, and legacy medical device ...

In an interview, C. Ola Landgren, MD, PhD, delved into the details of the FDA's draft guidance on using MRD as a basis for ...

FDA's Plausible Mechanism Framework streamlines individualized therapy approvals for ultra-rare diseases.

Patients living with severe chronic pain don’t only have to manage a debilitating affliction. They also have to deal with the FDA making it harder for them to access potentially life-changing new ...

Boehringer Ingelheim has become the second company to get a product approved under the FDA's national priority voucher ...

(THE CONVERSATION) The Food and Drug Administration’s decision, made public on Feb. 10, 2026, to not review an application to approve Moderna’s proposed mRNA-based flu vaccine set off a firestorm of ...

Jay Bregman, CEO and co-founder of Andel, discusses how FDA’s action signals a broader regulatory recalibration aimed at protecting intellectual property and explores the second-order effects.