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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

Under the terms of the agreement, Portola received $50m at closing and may receive an additional $100m upon US Food and Drug Administration (FDA) approval of AndexXa (andexanet alfa)

The applications are pertained for the use of Keytruda in patients having a type of bladder cancer termed urothelial cancer, in both locally advanced and metastatic stages. One