05/23/2017 - 4:46pm

According to the agency, this is the first time it has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated.

05/22/2017 - 1:44pm

Hoffman La Roche’s drug takes aim at the form of vasculitis, a group of disorders that results in inflammation of blood vessels.

05/19/2017 - 1:10pm

The oral therapy is administered twice daily for adults with an FLT3 mutation-positive acute myeloid leukemia diagnosis.

05/17/2017 - 5:17pm

According to the FDA, the expanded approval of Kalydeco triples the number of rare gene mutations that the drug can now treat, expanding the indication from the treatment of 10 mutations, to 33.

05/17/2017 - 3:11pm

During an analyst meeting, the company also said it will share its plans to continue driving sustainable growth by leveraging its strong portfolio of core blockbuster products, the “industry-leading” productivity of its innovation model, and the pending acquisition of Swiss-based biotech company Actelion.

05/17/2017 - 8:48am

The Natural Products Association on Tuesday expressed support of the reorganization of the Office of Regulatory Affairs by FDA.

05/16/2017 - 2:18pm

SB-525 uses a recombinant adeno-associated virus to deliver a human Factor VIII cDNA construct and proprietary, synthetic liver-specific promoter to the nucleus of liver cells with a single infusion.

05/12/2017 - 2:55pm

Steve Anderson participated in a listening session, one of a series of events intended to gather information and policy ideas from a wide variety of stakeholders which relate to the affordability, accessibility and availability of drugs for patients.

05/12/2017 - 12:25pm

Maine Sen. Susan Collins told the news outlet it was approved May 11 Collins says the measure is part of an investigation into "aggressive price hikes" in prescription drugs.