EMA

PBP1510 has already received ODD status from the US FDA in June 2020

The MHRA in the UK has granted Promising Innovative Medicine designation for avalglucosidase and US FDA has granted it…

It was based on evidence from clinical trials that demonstrated that subcutaneous administration of immunoglobulin has been shown…

The approval is based on results from the integrated analysis of the pivotal phase II STARTRK-2, phase I STARTRK-1 and phase I…

Companies will be required to have appropriate control strategies to prevent or limit the presence of these impurities and, where…

Inputs can be submitted until September 4 via an online questionnaire

The assessment of the benefits and risks of remdesivir is being performed under a reduced timeline and an opinion could be issued…

The new Ebola vaccine consists of two components, Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo). Zabdeno is given first and Mvabea…

Continuing its investigation into the presence of potential carcinogenic materials in various medicines, on May 28, the US FDA…

These facilities are used for the manufacture of DS and DP for Biosimilars: Bevacizumab, Trastuzumab, Pegfilgrastim and secondary…