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Abeona Therapeutics president & CEO Timothy Miller said: “This designation builds on our commercial portfolio of AAV gene therapies that have received FDA and EMA orphan drug designations, which is an

In addition, the FDA removed its partial clinical hold on a dosing ceiling for Resolaris in clinical trials. John Mendlein, PhD, CEO of aTyr Pharma, said: "This Fast

The Ireland based pharma maintained that it did not admit to any wrongdoing in the acquisition deal of synthetic ACTH product Synacthen Depot by Questcor Pharmaceuticals from Novartis

TAK-935 has successfully completed several Phase 1 clinical studies under Takeda’s leadership and will be moving into Phase 1b/2a clinical studies in rare epileptic encephalopathies where patients continue

Boehringer Ingelheim Therapeutic Area Biosimilars senior vice president and head Ivan Blanarik said: “We believe that if approved, BI 695501 can provide a valuable treatment option for the

Under the terms of the deal, which is anticipated to close by the end of the first quarter of this year, Lilly will pay $46.50 a share for

Suliqua is authorized for use in combination with metformin to improve glycemic control when this has not been provided by metformin alone or metformin combined with another oral

The deal, which gives Biogen a license to Forward Pharma’s intellectual property, could help the US company extend the life of Tecfidera. Under several circumstances outlined in the deal, Biogen will

Niraparib is being made available for eligible women in the U.S. with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer following a complete or partial response to