Topic:

Regulatory

Latest Headlines

Latest Headlines

Novartis' leading CAR-T cancer therapy gains breakthrough status at the FDA

The FDA has provided its special 'breakthrough' status for Novartis' closely-watched development program for a personalized CAR-T cancer therapy, promising to help speed development for engineered T cells.

Bristol-Myers' hep C combo wins Japanese OK, leading the pack

Bristol-Myers Squibb has become the first drugmaker to win regulatory approval for a combination hepatitis C treatment that doesn't require painful injections, picking up a Japanese nod for its all-oral cocktail.

FDA lowers regulatory bar for neurostimulators to treat headache

Soon, transcutaneous electrical nerve stimulation to treat headache will only require a 510(k), the FDA said in a July 3 final order published in the  Federal Register.

EU approves GSK's Mekinist and Novartis will reap the rewards

GlaxoSmithKline has notched another approval for its novel melanoma med Mekinist, and Novartis gets to celebrate. The drug, which the EU has approved for use there, is among those GSK is selling to the Swiss drugmaker in a $16 billion deal.

FDA unveils HeartWare warning letter for company's ventricular assist device

The FDA slapped HeartWare International with a formal warning letter one month after citing the company for safety issues related to its HeartWare Ventricular Assist Device system.

Senators call on White House to release FDA guidance on lab-developed tests

Five senate Democrats called for the White House Office of Management and Budget to release a long-sequestered FDA draft guidance on laboratory developed tests for public comment. In a letter to OMB acting director Brian Deese, they urged him to release the proposed regulation "to ensure appropriate and efficient oversight of diagnostic tools can move forward in an open and transparent manner."

U.S. voices concern over closed trial of American linked to GSK scandal

Until now, the widening soap opera that has left GlaxoSmithKline facing bribery charges in China seemed to be Britain's problem. But now the United States is stepping in, as China moves to try an American in a secret courtroom procedure starting August 7.

FDA begins to guide nanotechnology in animal feed

The FDA's new draft industry guidance on the use of nanomaterials in animal feed could ramp up production in drug delivery products for livestock, as companies scramble to find new ways of fattening them up--and faster.

FDA gets full buy-in for phaseout of antimicrobials

The FDA last year slammed drug companies for marketing antibiotics to production operators and farmers that weren't medically viable for their animals, but had more of a quick-fix function: getting them fat. Urged by the regulator, all of the animal health companies affected have voluntarily engaged with the FDA to help remove 283 of the products in question.

FDA IT modernization push set to continue under 2014-2018 strategic plan

When the FDA laid out its strategic priorities for 2011 to 2015, the agency listed the modernization of its IT infrastructure as a primary objective. Since then, the FDA has seen another chief information officer pass through its revolving doors and faced criticism from the Government Accountability Office, but is still plugging away with the IT modernization agenda in its next strategic plan.