implied or express statements regarding X4’s expectations related to the EMA’s evaluation of mavorixafor for WHIM syndrome; the potential for MAA approval in the European Union; X4’s plans ...

Telethon has submitted a marketing authorisation application (MAA) to the European Medicine ... "Italian charity seeks EMA approval for rescued gene therapy" was originally created and published ...

An even more major news would be an FDA review, but the EMA is a good second place. In my last coverage, I noted how the company “started” an MAA (the European application for approval over ...

implied or express statements regarding X4’s expectations related to the EMA’s evaluation of mavorixafor for WHIM syndrome; the potential for MAA approval in the European Union; X4’s plans ...

Gilead Sciences, Inc. announced that the European Medicines Agency (EMA) has validated for parallel accelerated review the company’s Marketing Authorization Application (MAA) and EU-Medicines ... in ...

Obtaining the Marketing Authorisation Application (MAA) is a key step in the commercialization of drugs in the EU, and also an important help to promote the global market expansion of pharmaceutical ...

In October, the EMA announced that it was looking to improve the efficiency of its approval process for new medicines in the European Union (EU). The stated aim for the agency was to better manage ...

The EMA PDCO approved the clinical program to evaluate ... a prerequisite for filing a Marketing Authorization Application (MAA). About acute Graft-versus-Host Disease Acute Graft-versus-Host ...

announces that it has obtained regulatory approval from the EMA (European Medicine Agency) to produce cell therapy treatments for the European market. C3i, therefore, obtains a certificate of GMP ...

Telethon has submitted a marketing authorisation application (MAA) to the European Medicine’s Agency (EMA) for evaluating ... cover the full development and approval process, which requires ...

including the New Drug Applications seeking FDA approval and the MAA and EU-M4all seeking EMA approval of lenacapavir for PrEP, and the risk that any regulatory approvals, if granted, may be ...