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The agency has assigned a Prescription Drug User Fee Act (PDUFA) action date of 10 April 2016 for BromSite, which has a long patent life extending to August

The agency has assigned a Prescription Drug User Fee Act (PDUFA) goal date of 01 April 2016 for a decision on this NDA and it reflects a Standard

The acquisition now expands the company’s suite of maternal health business and adds improved commercial capabilities as well as future growth opportunities to its portfolio. Currently, CBR’s storage

The contract with the Biomedical Advanced Research and Development Authority (BARDA) will fund activities related to current Good Manufacturing Practice (cGMP) manufacturing of a drug product and a

The focus of the collaboration, originally signed in 2014, is the development and validation of HiFiBiO’s proprietary, high throughput antibody discovery platform for deep mining of immune repertoires.

Envarsus XR, which received marketing authorization from the FDA on 10 July 2015, is indicated for the prophylaxis of organ rejection in kidney transplant patients converted from tacrolimus

Unituxin is administered in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and isotretinoin. Neuroblastoma is the most common extracranial solid cancer in childhood and the most common

Under the terms of the agreement, AVEO will receive an upfront payment of $15 million and will be eligible to receive reimbursement, clinical, sales and regulatory-based milestone payments

Said to be the first product approved through the partnership, Cefazolin injection is a cephalosporin antibacterial indicated for preoperative prophylaxis treatment. Galaxy is Baxter’s flexible container that makes