FDA

Catalyst Health Solutions, Inc., (NASDAQ: CHSI) today announced that AARP has selected Catalyst Rx as its new member benefit provider, responsible for providing millions of AARP members with access to discounts on their prescriptions.

Catalyst Pharmaceutical Partners, Inc. (Nasdaq: CPRX) today announced that the European Commission has granted orphan medicinal product designation for the company's investigational drug, CPP-115, a novel GABA aminotransferase inhibitor, for the treatment of West Syndrome (infantile spasms). The EC...

Medtronic, Inc. (NYSE: MDT) announced today the start of two clinical initiatives evaluating the broader, real-world clinical use of the company's Symplicity™ renal denervation system across multiple conditions. Furthering its leadership in the development of renal denervation therapy, Medtronic...

Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that results of a pivotal Phase 3 trial of HEPLISAV (HBV-10) were published online in the journal VACCINE. Data from this study will be used to support the HEPLISAV Biologics License Application (BLA) submission for an indication in...

A new study published in the journal Clinical Chemistry reported Abbott's (NYSE: ABT) ARCHITECT® Tacrolimus assay provides accurate and consistent medication monitoring for patients taking tacrolimus, an immunosuppressive medication, after receiving solid organ transplantation. Tacrolimus is a...

Shares of Chelsea Therapeutics (NASDAQ: CHTP) are seeing much pressure during Monday's pre-market session after the company updated shareholders of upcoming FDA panel review on its NORTHERA new drug application. During a presentation at the 14th Annual BIO CEO and Investor Conference president and...

Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it has received preliminary feedback, the Day 80 Assessment Report, from the European Medicines Agency regarding its Marketing Authorization Application for Adasuve™ (Staccato® loxapine). The ADASUVE MAA seeks approval for the rapid...

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Alkermes plc (Nasdaq: ALKS) today announced that BYDUREON™ (exenatide extended-release for injectable suspension) is now available by prescription in U.S. pharmacies. The U.S. Food and Drug Administration approved BYDUREON, the first and only once-...

Celsion Corporation (NASDAQ: CLSN) announced today that the first patient has been enrolled in a randomized Phase II study of the Company's lead product candidate, ThermoDox®, a heat-activated liposomal encapsulation of doxorubicin, in combination with radiofrequency ablation for the treatment of...

Horizon Pharma, Inc. (NASDAQ: HZNP) today announced that it has modified the DUEXIS® (ibuprofen/famotidine) Marketing Authorization Application submission to the National Procedure in the United Kingdom to include the recently approved Valeant Pharmaceuticals manufacturing site in Laval, Quebec (...