FDA Highlights ConOps Progress
ORA and CDER officials provided an update last month on the agency’s Concept of Operations initiative in a panel discussion at the FDLI Enforcement Litigation and Compliance Conference in Washington…
ORA and CDER officials provided an update last month on the agency’s Concept of Operations initiative in a panel discussion at the FDLI Enforcement Litigation and Compliance Conference in Washington…
In 2018, the European Medicines Agency’s quality and safety working groups intend to tackle several new guidelines, covering the sterilization of products and containers, risk-based prevention of cross contamination in…
With the J.P. Morgan Healthcare Conference now over, some analysts are looking back and picking out the "winners and losers" from the conference. Source: BioSpace
There are many unusual things about Shepherd Therapeutics, but one of them is its origin. Source: BioSpace
Strongbridge will fund 70% of the costs of a worldwide pediatric development program to be run by Aeterna Zentaris with customary oversight from a joint steering committee. Source: BioSpace
On Jan. 8, Alder BioPharma announced that its eptinezumab met its primary endpoint in its Phase III PROMISE 2 clinical trial for preventing migraine. Source: BioSpace
After a two year absence, Aveo returned to the halls of the key event with a drug newly approved for use in Europe and possibly poised for approval in the…
Thirty years ago, neurologist Leonard S. Schliefer, MD, PhD, founded Regeneron, a life sciences company dedicated to discovering, developing and bringing new medications to the patients who need them. Source:…
Kymriah became the first CAR-T cell therapy to receive regulatory approval when it was approved by the FDA in August 2017. Source: BioSpace
Chinese interest in the J&J unit comes as the market for diabetes care in China is expected to grow rapidly. Source: BioSpace