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The FDA has banned Canadian generics maker Apotex from importing drugs to the U.S. made at its Bangalore, India, site, pending quality upgrades. Read More
FDA approval of Stallergene’s under-the-tongue Oralair could be a huge boon for patients who suffer from hay fever and rake in billions more for the drugmaker, whose drug is already available in over two dozen countries. 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
Advocates for minorities and other patient groups that are underrepresented in clinical trials want the FDA to create incentives for drugmakers that include those groups in studies and become more aggressive in delaying drugs that don’t include them. 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
The European Medicines Agency has backed off of several controversial limitations that it was contemplating imposing on sponsors designing trials for treatments for chronic primary immune thrombocytopenia (ITP). 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
Massachusetts last week became the first state to ban Zogenix’s controversial painkiller Zohydro, a move that could lead other states to follow suit. Read More
The FDA Friday approved Janssen Pharmaceuticals’ Topamax for the prevention of migraines in adolescents, the first such drug for this age group. Read More