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 ...

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 ...

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 ...

MaaT Pharma (EURONEXT: MAAT ? the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for ...

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 ...

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 ...

The EMA's Committee for Medicinal Products for Human Use (CHMP) will review the MAA under the centralised ... interest in how this medication, if approved, could help transform efforts to end ...

Meanwhile, the European Medicines Agency (“EMA”) also validated the company’s Marketing Authorization Application (“MAA”) ...

Italfarmaco S.p.A. today announced a comprehensive update on the regulatory and clinical advancements for givinostat, the company’s drug for the treat ...

Discover how outsourcing regulatory submission content development improves efficiency and ensures compliance.

Operator Good morning, and welcome to Ocugen's fourth quarter and full-year 2024 financial results and business update.