FDA's long-standing accelerated approval program generally issues decisions in six months for drugs that treat life-threatening diseases. Regular drug reviews take about 10 months. Since arriving at ...

Kraft Heinz said it is working with licensees of its brands to encourage them to remove artificial colors, which are often referred to as FD&C colors because they can also be used in drugs and ...

Williams Farms Repack LLC announced on May 2 it was recalling tomatoes under the both the Williams Farm Repack label and the H&C Farms label for potential salmonella contamination.

The U.S. Food and Drug Administration plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65, effectively limiting their availability to older ...

The FDA’s recent activities regarding Covid-19 vaccines stray far from the well-established standards of vaccine regulatory processes.

Nucala (mepolizumab) approved by US FDA for use in adults with chronic obstructive pulmonary disease (COPD). News release. GSK. May 22, 2025.

The FDA’s decision appeared to render at least part of their discussion moot. The new restriction will sharply limit access to the Novavax vaccine for people younger than 65 who are in good health.

FDA Commissioner Marty Makary and top U.S. vaccines regulator Vinay Prasad wrote in the New England Journal of Medicine that the benefit of repeated annual shots for healthy adults was uncertain ...

MONDAY, May 19, 2025 (HealthDay News) — The U.S. Food and Drug Administration (FDA) has granted full approval to Novavax’s COVID-19 vaccine, but only for certain people.

The U.S. FDA has approved GE HealthCare’s Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) ultrasound enhancing agent for use in pediatric patients.

This isn’t the first time—or even the second—that the FDA has missed a decision target date this year. Early last month, the agency missed its April 1 target date to weigh in on a full ...

The FDA accepted the NDA for UGN-102, scheduled an ODAC meeting for May 21, 2025, and assigned a PDUFA target action date of June 13, 2025. About Low-Grade Non-Muscle Invasive Bladder Cancer (NMIBC) ...