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The European Medicines Agency has approved AstraZeneca’s Duaklir Genuair as a maintenance treatment for patients with chronic obstructive pulmonary disease. Read More
Manufacturers that adapt existing drugs and biologics to treat rare diseases could receive an additional six months of market exclusivity for the original indication under a new bipartisan House bill. Read More
Amgen pulled the plug on its experimental stomach cancer drug rilotumumab after data from two late-stage clinical trials raised serious safety concerns, marking the company’s second failed cancer drug this month. Read More
The European Commission has approved Eli Lilly’s self-injectable diabetes drug Trulicity, a move that follows the FDA’s approval in September. Read More
India’s drug pricing authority has proposed adding 12 cancer drugs to its list of essential therapies that are subject to price controls, while removing three under-utilized drugs. Read More
The European Medicines Agency wants to improve the access to its unpublished documents, but still reserves the right to refuse a request if disclosure would undermine protected information such as the purpose of an investigation or audit into a company. Read More
In observance of the Thanksgiving holiday, Drug Industry Daily will not be published Thursday, Nov. 27, or Friday, Nov. 28. The next issue will be published Monday, Dec. 1. Read More
By the end of next year the FDA is expected to release rules on drug shortages, biologic safety testing, compounding pharmacy oversight and OTC monographs on cough and cold medicines. Read More
As part of an initiative to increase clinical trial transparency, the FDA has launched a website that provides information about the sex, age, race and ethnicity of participants in studies that support drug approvals. Read More
Merck has gained exclusive licensing rights to an experimental Ebola vaccine that is still undergoing clinical trials under a deal with NewLink Genetics. Read More