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Swiss health authority Swissmedic has approved Novartis’ Entresto, enabling other health authorities to complete their reviews of the heart failure drug. Read More
Antibiotics developer Cempra said Friday the FDA granted a qualified infectious disease product designation for its investigational candidate Taksta to treat acute bacterial skin and skin structure infections. Read More
A trial of a cervical cancer treatment by New Jersey biotech company Advaxis demonstrated it could extend life further than existing treatments in women with persistent, advanced forms of the disease. Read More
Drugmakers making changes to analytical methods over the lifecycle of a drug should retain samples to permit comparative studies of the new and old methods, the FDA says. Read More
Drugmakers in the EU have less than seven months to conduct risk assessments of all the excipients they use under good manufacturing practices guidelines imposed by the European Commission. Read More