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FDA Delays Review on Collegium Pain Drug

[ Price : $8.95]

Despite a unanimous vote by an advisory committee to recommend approval, FDA tells Collegium Pharmaceutical, Inc, that it was not...

FDA Clears Baxters Home Dialysis System

[ Price : $8.95]

FDA clears a Baxter International 510(k) for the home-based AMIA automated peritoneal dialysis system with the ShareSource Web-bas...

FDA Fast Track for Portola Blood Thinner

[ Price : $8.95]

FDA grants Portola Pharmaceuticals a fast track designation for betrixaban for extended-duration prevention of venous thromboembol...

OCI Probe Behind Indictment Against AWD Group

[ Price : $8.95]

A federal grand jury indicts Jorge L. Pagn Kortright and his companies AWD Group Inc. doing business as El Torito USA, Inc., Allie...

FDA Posts Qualgen Form-483 from Sept. Inspection

[ Price : $8.95]

FDA cites Edmond, OK-based Qualgen for not having separate or defined areas and control systems to prevent contamination or mix-up...

FDA Reclassifies Shortwave Diathermy

[ Price : $8.95]

Federal Register Final order: FDA reclassifies shortwave diathermy for all other uses into Class 2 and renames the device.

FDA Clears NuVasive X-Core Cervical Corpectomy Device

[ Price : $8.95]

FDA clears a NuVasive 510(k) for its X-Core Mini Cervical Corpectomy System, an expandable titanium vertebral body replacement dev...

Cook Medical Expands Recall of Angiographic Catheters

[ Price : $8.95]

Cook Medical expands an earlier recall to include select sizes of its Beacon Tip Angiographic Catheters because the devices have b...

FDA Breakthrough Status for Rebiotix C Diff Candidate

[ Price : $8.95]

FDA grants a breakthrough therapy designation request to Rebiotix for its Microbiota Restoration Therapy (MRT) RBX2660 for treatin...

Rare Disease Fund Act of 2015 Introduced in House

[ Price : $8.95]

Representatives Thomas J. Rooney (R-FL) and Juan Vargas (D-CA) introduce the Rare Disease Fund Act of 2015 that seeks to act as a ...