BioSpace News Archive

The results support the use of pathological complete response (pCR) as a primary endpoint for accelerated approval of new drugs.

Commissioner Scott Gottlieb announced the proposal in a blog posted on the FDA’s website.

The CHMP has provided the Day 195 List of Outstanding Issues (LoOI) to the company with a request for responses during the next available submission window of January 23, 2018.

SSI announces the release of its MALDI-8020, marking SSI’s return to benchtop matrix assisted laser desorption ionization time of flight mass spectrometry.

Mr. Davis joins the organization with over 30 years of experience in leadership and business development, strategic planning and creating joint ventures across the US, Europe and Japan.

Soleno intends to use the net proceeds from the offering to conduct the planned Phase III program of DCCR in PWS.

Surgery to remove a part of the brain to give relief to patients with epilepsy doesn’t always result in complete seizure relief, but statisticians at Rice University have developed a method for integrating neuroimaging scans to identify patients at high risk of continued seizures before the surgery takes place.

The company’s lead compound, is being evaluated in Phase 3 and Phase 2 clinical trials in both intravenous and oral forms, respectively.

The company will also hold a live investor conference call and webcast at 8:30am Eastern Time.

The Corporate Advisory Board comprises accomplished and highly regarded medical opinion leaders within dermatology and aesthetics.