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The target date for the FDA to take action under the Prescription Drug User Fee Act is 29 May. If approved by FDA, the drug would be the

The approval expands treatment options for pediatric patients aged 1 year and above with chronic ITP who have not responded to other therapies. Two formulations have been approved

The randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, phyarmacodynamics, and glucose and insulin dose-lowering properties of REMD-477 in up to 20 patients with type 1 diabetes

These agreements relate to Eisai’s global oncology therapies, Halaven (eribulin) and Lenvima (lenvatinib), as well as the Company’s global epilepsy therapy, Fycompa (perampanel). Under the proposed agreements, important

Additionally, Incyte has amended its Collaboration and License Agreement with Novartis, granting Novartis exclusive research, development and commercialization rights for ruxolitinib in GVHD outside the U.S. "We are

Lumos will use the proceeds for clinical trials and commercialization of its lead compound, LUM-001, for the treatment of Creatine Transporter Deficiency (CTD). Funding will also be used

Under the deal, Allergan will pay $125m upfront to Heptares for exclusive global rights to a portfolio of treatments for neurological disorders. Heptares is also eligible for milestone

The drug is already approved in Europe for use in previously treated patients with metastatic squamous NSCLC. Opdivo’s indication has now been expanded to include non-squamous NSCLC, which

Based on these data, Ironwood intends to discontinue development of IW-9179 for gastroparesis. "Our mission is to bring innovative medicines to patients in need, and exploratory trials are