OR WAIT null SECS
July 02, 2020
EMA is facing a dilemma in trying to restore activities back to normal after relocating and the COVID-19 pandemic.
FDA Commissioner Hahn commits to a science-based review and approval process.
July 01, 2020
While there currently is no molecular therapy targeted against the PAUFgene, Prestige believes its monoclonal antibody has the potential to benefit patients affected by PAUF-positive pancreatic cancer.
Phesgo is a fixed-dose-combination subcutaneous injection of Perjeta (pertuzumab) and Herceptin (trastuzumab) for treating HER2-positive breast cancer.
The complete response letter was issued for a biologics license application for Abicipar pegol, an investigational treatment for wet age-related macular degeneration, based on FDA’s determination of an unfavorable benefit–risk ratio.
June 25, 2020
Novartis UK has issued a statement specifying its disappointment at the initial decision by NICE to not recommend Mayzent (siponimod) for the treatment of secondary progressive multiple sclerosis with active disease.
The European Medicines Agency’s (EMA’s) Committee for Human and Medicinal Products (CHMP) has recommended Veklury (remdesivir) be granted conditional marketing authorization in the European Union for the treatment of COVID-19.
June 23, 2020
The agency will be waiving fees for scientific advice for academia developing orphan drugs.
June 22, 2020
Nabriva Therapeutics reports that FDA says travel restrictions are preventing the on-site inspection of a European contract manufacturer.
June 17, 2020
The guidance provides recommendations on statistical considerations to address the impact of COVID-19 on meeting trial objectives for clinical trials conducted during the pandemic.