FDA Awards Priority Review to Gilead for Hep C Combo Drug January 11, 2016 The drugmaker’s case for the NDA stems from four international Phase 3 trials. Read More
LifeSciences’ Omnigraft Snags New Indication January 8, 2016 The new indication is to treat certain diabetic foot ulcers. Read More
Discoloration Sparks PharMEDium Recall of Norepinephrine Bitartrate January 8, 2016 The recall affects 29 lots of the 4-mg version and three lots of the 8-mg version. Read More
Smith & Nephew Completes Blue Belt Holdings Buy January 7, 2016 Blue Belt specializes in the field of orthopedic robotics-assisted surgery. Read More
Dherbs Hit With Warning Letter for Selling Unapproved Supplements January 7, 2016 Several of its products include labeling that would cause them to be drugs. Read More
FDA Alerts Puerto Rican Facilities of Customed Convenience Packs January 6, 2016 The products were not tested for integrity, safety and efficacy. Read More
AbbVie Requests FDA Hearing on Biosimilar Interchangeability Guidance January 6, 2016 The hearing would allow stakeholders — including manufacturers and payers — to examine multiple topics. Read More
Conmed Completes SurgiQuest Buy January 5, 2016 SurgiQuest is the manufacturer of the AirSeal system. Read More
Court Upholds $113M Award to PharmAthene from Siga January 5, 2016 Whether the biodefense company receives the money remains to be seen. Read More
Theragenics Acquires Eckert & Ziegler Seed Business January 4, 2016 The transaction will help Theragenics improve its work on prostate brachytherapy. Read More
Judge Throws Out NYU Claim Against Pfizer January 4, 2016 NYU maintained that Pfizer owed royalties for a lung cancer drug the school said it was instrumental in making. Read More
NeuroMetrix Initiates Mexican Launch of DPNCheck December 30, 2015 The device is a quantitative nerve conduction test for the detection of diabetic neuropathy. Read More