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A rolling submission is intended to accelerate the review process by enabling review of portions of the NDA by the FDA prior to submission of the complete application.

The intellectual property was developed at the Henry Ford Hospital System, Detroit, Michigan, by Drs. Michael Chopp, Daniel Morris, and Zhenggang Zhang, and in-licensed by RegeneRx Biopharmaceuticals, Inc.

Cara’s formulation of oral CR845 will continue to utilize Enteris’ proprietary oral delivery technology under a renewed and revised Manufacturing and Clinical Supply Agreement. The new agreement includes

VK5211 is an orally available, non-steroidal selective androgen receptor modulator (SARM) being developed for the treatment of patients recovering from non-elective hip fracture surgery. Viking intends to commence

Rett syndrome primarily affects females with an estimated prevalence ranging from one in 10,000 to 20,000 females and there are no approved treatments available. In preclinical testing with

Being conducted across multiple centers in Australia and New Zealand, the trial will determine the efficacy of a once daily oral dosing regimen for BGB-283 in solid tumors

The company’s partner, Sanofi, will re-submit a file to the Mexican health agency to seek approval of the 1mg/vial presentation of Egrifta which is currently marketed in other

The Memantine hydrochloride tablets are the generic version of Forest laboratories’ Namenda Tablets. The company has also received final approval from the US Food and Drug Administration (FDA)

NPI markets and distributes nutraceuticals, dietary supplements, skin care products and more, both in the US and international markets. Creative Medical Health chief executive officer Timothy Warbington said: