Keyword: Complete Response Letter
The FDA has shot down Enzyvant's RVT-802, a rare immunodeficiency disease candidate, citing manufacturing concerns.
Sarepta’s chief Doug Ingram has come out against accusations that the FDA is biased against the company after its recent drug rejection.
Vanda Pharmaceuticals received a Complete Response Letter from the FDA taking issue with a small study testing Hetlioz in jet lag disorder.
Eli Lilly and Incyte were expecting an approval this weekend from the FDA for their blockbuster-in-waiting arthritis candidate baricitinib, but today announced that the agency wants more trial data, adding significant delays and costs.
GlaxoSmithKline has one of the lowest R&D budgets in percentage of revenue terms of its peers; although its research budget was slightly up on 2015, this is still markedly down from the around £4 billion it was spending in 2012-13.
Cempra has pulled a filing for approval of its antibiotic candidate solithromycin in the European Union.
Buried deep down in Novartis’ Q2 results out this morning was a previously unknown rejection by the FDA for a copycat version of Amgen’s blockbuster drug Neulasta (pegfilgrastim).
