News

GSK's asthma drug wins FDA approval to treat 'smoker's lung'
The U.S. Food and Drug Administration has approved British drugmaker GSK's asthma drug to treat some patients with a chronic ...
With vaccine approval process set to change, FDA advisers leave wiggle room in annual Covid-19 shot recommendations
A group of experts who advise the US Food and Drug Administration on its vaccine decisions voted unanimously Thursday to make ...
Prices for new US drugs doubled in 4 years as focus on rare disease grows
U.S. President Donald Trump's trade negotiators are pushing the EU to make unilateral tariff reductions on U.S. goods, saying ...
FDA to limit covid shot approval to 65+, those with medical conditions
The FDA will narrow its approval for updated coronavirus vaccines, marking a significant shift in the agency’s approach to ...
FDA will limit approval for seasonal COVID vaccines: What to know
Healthy younger adults and children will no longer be automatically approved for annual COVID-19 vaccines under a new policy ...
Trump’s FDA limits annual COVID shot approval for healthy adults, children
Top officials for the Food and Drug Administration laid out new requirements for yearly updates to COVID shots, saying they’d ...
Trump FDA overhauls COVID-19 vaccine approval to focus on older populations, high-risk individuals
The FDA announced a policy shift for COVID-19 vaccine approvals to focus on Americans considered high-risk of contracting the ...
FDA sets new COVID booster guidelines requiring trials for approvals for healthy adults
The U.S. Food and Drug Administration plans to require new clinical trials for approval of annual COVID-19 boosters for ...
C&EN10d
How will FDA changes reshape drug approval in 2025 and beyond?
Kennedy Jr. Industry observers say this year may be characterized by slower ... because regulators in many other countries expedite review of FDA-approved drugs. The FDA becomes involved before ...
FDA to revisit approval of "yoga mat" bread ingredient banned in Europe
The FDA is prioritizing the review of some previously approved food additives, including ADA, dubbed the "yoga mat" chemical.
MPR3d
FDA’s New COVID-19 Vaccine Approval Policy May Limit Future Access
According to Makary and Prasad, the US’s adoption of a “one-size-fits-all” guidance for COVID-19 vaccination departs from ...
Healio3d
FDA Recap: April, May big months for intervention, electrophysiology approvals
Recent FDA updates in the areas of cardiac intervention, hypertension and arrhythmia disorders expand the pool of available ...