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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
GlaxoSmithKline has joined a list of drugmakers whose non-small cell lung cancer (NSCLC) drug candidates have failed in Phase III trials in the past year. Read More
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
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