The European Medicines Agency should upgrade its user testing of drug packaging inserts and other product information for patients over the next 18 months in carrying out recommendations from the…
The FDA published a draft guidance explaining the new biosimilar fee structure under BsUFA II and the types of fees that took effect Oct. 1. The draft also covers how…
Commissioner Scott Gottlieb said there’s no better time for him to work at the FDA, with a slate of new agency authorities providing a “watershed opportunity” to shape the regulatory…
The drug, in combination with abemaciclib, showed 16.4 Months of progression-free survival. Source: BioSpace
Two months after positive preliminary data showed sitravatinib in combination with Opdivo demonstrated some efficacy in treating patients with NSCLC, Mirati said it will reprioritize its R&D to focus. Source:…
Every year, Forbes creates lists of "30 Under 30" leaders in various industries who are under the age of 30. Source: BioSpace
Data from Amgen's Fourier study supports the use of Repatha to reduce the risk of recurrent cardiovascular events in patients with a history of multiple heart attacks. Source: BioSpace
Arvinas expanded an ongoing licensing deal with Genentech. Source: BioSpace
We write about science every day, why isn’t it getting through to the public consciousness? Source: BioSpace
The $49M in Series A funding will be used to develop the company's enzyme replacement therapies for two rare diseases affecting infants and children and push the treatments into the…