The European Medicines Agency (EMA) has approved an additional 2 mL pre-filled pen option for subcutaneous administration of Takeda’s Takhzyro (lanadelumab), aimed at treating hereditary angioedema ...

The EMA is looking for pharma companies that are about to submit marketing applications for products to participate in the pilot, which is expected to last two years and cover up to ten regulatory ...

As part of the regulatory process for the registration of new medicines in Europe, the EMA requires pharmaceutical companies to provide a PIP detailing their strategy for investigation of the new ...

Heads of R&D at all major pharma companies have come together to express their concerns about severe disruption to the European Medicines Agency (EMA) as it faces a Brexit-induced relocation.

Vertex Pharmaceuticals (NASDAQ:VRTX) announced Friday that an expert panel of the EU drug regulator, the European Medicines ...

Novartis (NVS) announced that the Committee for Medicinal Products for Human Use, CHMP, of the European Medicines Agency, EMA, has adopted a ...

Pharmaceuticals announced that the European Medicines Agency’s, EMA, Committee for Medicinal Products for Human Use, CHMP, has ...

Following a flurry of activity at this month’s meeting of the European Medicines Agency’s Committee for Medicinal Products ...

Ph.D., president and chief executive officer of X4 Pharmaceuticals. “With our MAA now validated for review by the EMA, we expect to enable our recently announced European partner, Norgine, to provide ...

The report, released at Global Pharmaceutical Quality Summit in Mumbai, draws comparison of incidences of ‘official action indicated' after USFDA inspections a decade apart.