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With its controversial painkiller Zohydro already banned in Massachusetts and federal lawmakers looking to follow suit, Zogenix has initiated a fierce lobbying campaign to save its flagship product. Read More
Small and medium-sized drugmakers will be able to pay lower — and in some cases, no — fees for certain postauthorization activities under new incentives announced Tuesday by the European Medicines Agency. Read More
Republican lawmakers Tuesday blasted CDER Director Janet Woodcock for the FDA’s consulting with trial attorneys and not brand or generic drugmakers when developing a controversial proposed overhaul of generic drug labeling rules. Read More
Drugmakers must now give Brazil’s ANVISA a full year’s warning before withdrawing a product from the market if the withdrawal could result in a drug shortage. Read More
Novartis said Monday it has halted the Phase III trial of its chronic heart failure drug LCZ696 after being notified by a data monitoring committee that the drug met its composite primary endpoint of delayed cardiovascular death and reduced heart failure hospitalizations. Read More
The FDA has outlined the annual fees that large drug compounders that register as outsourcing facilities will have to pay the agency under new federal law. Read More
Japanese drugmaker Eisai’s U.S. subsidiary is selling and assigning its U.S., Canadian and Japanese development and marketing rights to Dacogen to Otsuka Pharmaceuticals. Read More
The FDA said Thursday that all manufacturers have voluntarily complied with an agency ban on selling acetaminophen/opioid combination drugs that use more than 325 mg of acetaminophen per tablet. Read More