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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

The two companies confirmed media reports of the proposed offer from Reckitt Benckiser but stated that they were yet to reach a definitive agreement. Reckitt Benckiser, which is

The PIM designation is the first step towards inclusion in the Early Access to Medicines Scheme (EAMS).  Launched in April 2014, EAMS offers severely ill patients with life-threatening

The round was led by new investor Versant Ventures. Existing investors New Enterprise Associates, Novo A/S, NanoDimension and Flagship Pioneering also participated. Tarveda plans to use these financial

Milan Zdravkovic, Senior Vice President, Chief Medical Officer, and Head of Research & Development at Sobi, said: “Sobi has a long-term commitment to improve the lives for people

With this expanded capacity, Arven will support local healthcare needs by bringing biopharmaceuticals to the Turkish and surrounding markets faster, whilst also opening up European markets through the

The priority review status will reduce the review clock to six months from the standard 10 months. Even though the action date is not specified, it is expected