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Drugmakers seeking marketing authorization in Australia will soon be able to make complete submissions in electronic format, allowing for cost savings and potentially swifter reviews. Read More
As calls for revoking the FDA’s approval of Zogenix’s painkiller Zohydro ER continue to grow, lawmakers are now questioning whether a public-private industry partnership tainted the agency approval process. Read More
The FDA is proposing that physicians be allowed to perform fecal matter transplants (FMT) in limited circumstances without an investigational new drug (IND) application, provided the physician or their patient knows the donor. Read More
FDA advisors Wednesday urged the agency to rescind the OTC bronchodilator monograph for epinephrine and racepinephrine products delivered via a hand-held rubber bulb nebulizer, saying the combination products present safety concerns that only an NDA can address. Read More
The FDA Tuesday released new information that shows the scope of its efforts to investigate the efficacy and bioequivalence of generic drugs, publishing summaries of ongoing research. Read More
Preliminary data from a late-stage trial of Eli Lilly’s type 2 diabetes drug dulaglutide positions the candidate as a major contender in the increasingly competitive drug class known as GLP-1. Read More
Amarin has received more bad news from the FDA, which granted its prescription fish oil pill just three years of exclusivity instead of five — a decision limiting market power for the drug as it struggles to win an expanded indication. Read More
The FDA is proposing to extend new chemical entity (NCE) market exclusivity for certain fixed-dose combination (FDC) drugs from three to five years, bowing to industry and congressional demands that more incentives are needed to pursue the costly products. Read More