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Perrigo has notified Valeant Pharmaceuticals North America LLC and Dow Pharmaceutical Sciences, Inc. (Valeant) the owner of both the New Drug Application and patents listed in FDA's Orange

The company claims that Parsabiv is the first new therapy approved for the condition in 12 years. It is designed to be administered intravenously three times per week

The company has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA). Ariad’s US marketing application is currently under the US Food and Drug Administration

The addition of Vault Submissions Publishing unifies publishing capabilities and enterprise content management to streamline end-to-end submission development. Now life sciences companies can plan, review, publish, archive, and

Clinical investigators will assess the safety and efficacy of Immunovaccine's DPX-Survivac cancer vaccine candidate in combination with Merck's checkpoint inhibitor Pembrolizumab in patients with recurrent, platinum-resistant ovarian cancer.

Concurrently, Chondrial announced the licensing of a novel investigational technology, CTI-1601, for the treatment of Friedreich's Ataxia from Indiana University Research and Technology Corp. (IURTC) and Wake Forest

The phase 2 trial featured 145 adult patients with insomnia disorder where both 5 and 10mg strengths of the hypnotic drug met the primary endpoint while resulting in

No new safety issues were observed. The EBBINGHAUS cognitive function trial conducted in FOURIER patients also achieved its primary endpoint, demonstrating that Repatha was non-inferior to placebo for

The FDA has determined that the Company’s application is sufficiently complete to permit a substantive review, and has set a target action date under the Prescription Drug User