The Trump administration will respond to a citizen petition calling for the overhaul of ultra-processed foods regulation, ...
The FDA has approved Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) as the first and only subcutaneous, chemo-free ...
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FDA blindsides Moderna with refusal to review flu vaccine application: ‘We’re pretty confused’
The Food and Drug Administration refused to review Moderna’s application for its new mRNA flu vaccine — a move the pharma ...
In an interview, Moderna President Stephen Hoge took questions on an FDA decision on the biotech's mRNA flu vaccine, as well ...
The head of the Food and Drug Administration (FDA) says that while the Trump administration is taking the potential harms of marijuana use among youth “very seriously,” it’s also important to preserve ...
The US Food and Drug Administration's (FDA’s) Center for Biologics Evaluation and Research (CBER) is refusing to review Moderna’s application for approval of a new flu vaccine. The decision comes ...
A year of significant policy change at the FDA brought momentum and scrutiny into the new year. As 2026 gets underway, biopharma companies are responding to sweeping vaccine changes while concerns ...
Moderna Inc.’s shares fell after US regulators refused to review its novel mRNA flu vaccine, creating regulatory chaos for the pharmaceutical industry and offering another example of the Trump ...
A batch of untitled letters posted on the FDA’s database in recent days takes aim at what the agency has termed “false or misleading” drug ads from the likes of Novo Nordisk, argenx and Sobi. | A ...
The FDA laid out the qualifications a site would need to qualify for PreCheck on a webpage where companies can also submit requests to take part in the program. Companies are limited to one submission ...
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