Topic:

Regulatory

Latest Headlines

Latest Headlines

USDA gives conditional approval for Zoetis PEDv vaccine

The U.S. Department of Agriculture has given conditional approval for use of Zoetis' vaccine to combat the porcine epidemic diarrhea virus, or PEDv, that has caused havoc in global swine herds, killing an estimated 8 million piglets in the U.S. alone since it was first reported more than a year ago.

Kentucky Horse Racing Commission looking into regulating compounders

The commissioner of the Kentucky Horse Racing Commission announced that the organization is looking into ways it can add regulatory oversight of drug compounders.

GE wins approval of 3-D imaging tech for breast screening

GE today announced the approval of its SenoClaire breast tomosynthesis device that employs 3-D imaging, developed in collaboration with Massachusetts General Hospital. 

Governors to HHS secretary: Nix that FDA nod for controversial painkiller Zohydro

Count five U.S. governors among the lobbyists for a turnabout on the powerful painkiller Zohydro. The New England politicians wrote Health and Human Services Secretary Sylvia Burwell last week, urging her to yank the drug's FDA approval.

UPDATED: Will little-known company's inhaled candidate take down InterMune-Roche's pirfenidone?

Roche's announcement that it will acquire InterMune and its orally delivered drug pirfenidone has pushed the rare lung condition idiopathic pulmonary fibrosis (IPF) into the spotlight. Boehringer Ingelheim also has an oral drug for IPF on the horizon, but a little-known candidate for the condition has the potential to steal the big boys' thunder due to its differentiated delivery mechanism. 

FDA clears wireless, vitals monitor patch that transmits to smartphone

The FDA has cleared HealthPatch MD, a small, wireless biosensor patch worn on the chest that can track a number of vital signs and biometric measurements. The sensor connects to a smartphone to relay data to a healthcare provider.

Medical device excise tax repeal remains a top Republican priority

A plan to repeal the medical device tax enacted in 2010 might be in the works among Republican senators gearing up for the expected GOP majority in Congress.

Acadia surges after nabbing 'breakthrough' title for late-stage Parkinson's drug

The FDA has just added a fresh boost to Acadia Pharmaceuticals, naming its late-stage Parkinson's drug pimavanserin a "breakthrough" therapy deserving rapid regulatory response as it nears the finish line with a closely watched marketing application.

Amazon's meeting with FDA starts the rumor mill turning

Amazon is the latest tech giant to consider expanding into healthcare, but details of the online retailer's plans are sketchy.

FDA clearance of Medtronic's scoliosis implant a much-needed victory for pediatric devices

Pediatric devices are in short supply because of the prevalence of rare diseases in children, as well as their unique physiology. So, FDA's 510(k) clearance of Medtronic's Shillla Growth Guidance System for the treatment of scoliosis in children less than 10 years old has particular significance.