A federal judge on Monday blocked a Food and Drug Administration requirement that tobacco companies put big new graphic warning labels on cigarette packages by next September.
American and European regulators issued safety alerts on Thursday about Multaq, a drug approved two years ago to treat abnormal heart rhythms.
The Food and Drug Administration said a study of the drug in patients with a long-term form of the disease, known as atrial fibrillation, showed twice as many deaths as those who did not take the drug.
The Food and Drug Administration on Wednesday approved Brilinta, a new blood thinner from AstraZeneca that the company hopes can rival Plavix, the No. 2 best-selling drug in the world.
The agency will require a boxed warning about how the drug
AstraZeneca is adding a new heart warning to the labels of Seroquel, its blockbuster antipsychotic drug, at the request of the Food and Drug Administration, company and agency officials said on Monday.
Warnings for Seroquel will soon recommend that the drug be avoided in combination with 12 drugs linked to arrhythmia.
The revised label, posted without fanfare last week on the F.D.A.
