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- Read more about Theravance Biopharma get FDA Approval of Expanded Label for VIBATIV(R) (telavancin)
Theravance Biopharma, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Company's supplemental New Drug Application (sNDA) for VIBATIV® (telavancin) to expand the product's label to include data describing the treatment of patients with concurrent Staphylococcus aureus (S. aureus) bacteremia in both of the antibiotic's currently approved indications in the United States.
- Read more about U.S. FDA Update Abbvie’s IMBRUVICA® (ibrutinib) Label to Include Overall Survival Data
AbbVie announced, the U.S. Food and Drug Administration (FDA) updated the IMBRUVICA® (ibrutinib) Prescribing Information (PI) to include new data from two Phase 3 trials supporting its expanded use in patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The label now includes overall survival (OS) results in previously-untreated CLL/SLL patients from the Phase 3 RESONATETM-2 (PCYC-1115) trial.
- Read more about Allena’s Investigational Therapy Receive Orphan Drug Designation from U.S. FDA
Allena Pharmaceuticals, Inc announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Allena’s investigational therapy oxalate decarboxylase for the treatment of pediatric hyperoxaluria.
- Read more about BIND Therapeutics enter into Research Collaboration with Affilogic to develop ACCURINS
BIND Therapeutics, Inc. announced a research collaboration with Affilogic, a privately held biotechnology company developing affinity proteins called Nanofitins® that selectively bind and interact with identified targets.
- Read more about Cardiome and Allergan Sign agreement to commercialize XYDALBA™ in International Markets
Cardiome Pharma Corp. announced that it has signed an exclusive license agreement with an Allergan to commercialize XYDALBA™ (Dalbavancin) in France, the U.K., Germany, Belgium, Nordic nations, certain other European nations (not already partnered), various Middle Eastern nations and Canada.

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- Read more about Concert Pharmaceuticals disclose launch of CTP-543 for Treatment of Alopecia Areata
Concert Pharmaceuticals Inc. announced launch of CTP-543 for the treatment of alopecia areata. Alopecia areata is an autoimmune disease characterized by patchy or widespread hair loss, for which there is significant unmet medical need and currently no FDA-approved treatment. CTP-543 is a deuterium-modified analog of ruxolitinib, which selectively inhibits Janus kinases 1 and 2, known as JAK1 and JAK2.
- Read more about Aurobindo Pharma fenofibrate Tablets get-USFDA approval
Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Fenofibrate Tablets, 48 mg and 145 mg. Fenofibrate Tablet is used to treat high level of cholesterol and triglyceride in the blood. Product is expected to be launched in Q1 FY16-17.
- Read more about Colorcon Opened New Film Coating Manufacturing Plant in Brazil
Colorcon Inc. Opened new film coating manufacturing plant in Indaiatuba – Sao Paulo State, Brazil. The construction is scheduled for completion by October 2016 with the production of commercial scale product scheduled for January 2017.
- Read more about Ferring Pharmaceuticals NOCDURNA® get approval in EU
Ferring Pharmaceuticals announced that NOCDURNA® (desmopressin) has received approval in the EU. It is used for the symptomatic treatment of nocturia due to idiopathic nocturnal polyuria in adults. Nocturia is complex medical condition with the need to wake and pass urine at night.
- Read more about LabStyle get European patent for Dario diabetes management tool
LabStyle Innovations Corp., announced that it has been granted a key patent by the European Patent Office (EPO) for the company’s personalized blood glucose monitoring device. The Dario smart glucose monitoring device is designed to work in tandem with LabStyle’s novel and powerful Dario software application to form the overall Dario Diabetes Management Tool.