USFDA

Innocoll  announced that it has received a Refusal to File letter from the United States Food and Drug Administration (FDA) for XARACOLL, the company’s product candidate for the treatment of postsurgical pain.

Cempra, Inc. announced that the company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) relating to the company's new drug applications (NDAs) for oral and intravenous solithromycin for the treatment of community-acquired bacterial pneumonia (CABP) in adults.

The U.S. Food and Drug Administration (FDA) approved  Biogen’s SPINRAZA™ (nusinersen) under Priority Review for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. SPINRAZA is the first and only treatment approved in the U.S. for SMA, a leading genetic cause of death in infants and toddlers that is marked by progressive, debilitating muscle weakness.

Cipla Ltd, a global pharmaceutical company, has yielded a final approval for its lead MDI product Fluticasone + Salmeterol (Sereflo) from UK MHRA for its partner in the UK.

GenMark Diagnostics, Inc., a leading provider of automated, multiplex molecular diagnostic testing systems, has submitted 510(k) applications to the FDA for its ePlex sample-to-answer instrument and Respiratory Pathogen Panel.

Avinger, Inc., a leading developer of innovative treatments for Peripheral Artery Disease (PAD),  announced that the company has received a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Lightbox L250 imaging console. With this new FDA clearance, the Lightbox L250 now provides detailed measurement of vessels with a few simple taps to a touch screen, helping further improve visualization inside the vessel before, during, and after Pantheris™ Lumivascular atherectomy procedures for the treatment of PAD.

Janssen Biotech, Inc. (Janssen) announced the submission of two Supplemental Biologics License Applications (sBLAs) to the US Food and Drug Administration (FDA) seeking approval of Simponi Aria (golimumab) for the treatment of adults living with active psoriatic arthritis and the treatment of adults living with active ankylosing spondylitis (AS).

Biocartis Group NV (‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART),  announced the 510(k) submission to the U.S. Food and Drug Administration (FDA) of its rapid, fully automated molecular diagnostics platform Idylla™, consisting of the Idylla™ Instrument and the Idylla™ Console.

Vernalis plc and Tris Pharma, Inc. are pleased to announce that the U.S. Food and Drug Administration ("FDA") has accepted the CCP-08 New Drug Application ("NDA") for full review. This triggers a milestone payment from Vernalis to Tris. The FDA has set a Prescription Drug User Fee Act ("PDUFA") target date for conclusion of its review of 4 August 2017.

Cipla Ltd, a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients, has received final approval for its Abbreviated New Drug Application (ANDA) for Fenofibrate Tablets USP 48mg and 145mg, from the United States Food and Drug Administration (USFDA).