Mía had dystrophic epidermolysis bullosa, better known as butterfly skin due to the extreme fragility of this tissue in ...

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 European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended three novel medicines for approval at its ...

Jaguar expects first results in Q2 2025 of proof-of-concept investigator-initiated trials of crofelemer for the rare diseases short bowel syndrome with intestinal failure and microvillus inclusion dis ...

When comparing the FDA and EMA, we found that many of the calculations that determine this relative speed have used time of approval and time of market authorization, interchangeably. This ...

Takeda (TAK) announced that the EMA has approved an additional two mL pre-filled pen option for Takhzyro for subcutaneous administration in adolescents and adult patients with Hereditary Angioedema.

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 ...

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 ...

EMA committee recommends approval of AstraZeneca’s Imfinzi in combo with chemotherapy to treat resectable non-small cell lung cancer ...

if approved, could help transform efforts to end the HIV epidemic globally,” said Dietmar Berger, MD, PhD, Chief Medical Officer, Gilead Sciences. The EMA applications are supported by data from ...

MaaT Pharma Receives Positive Opinion from EMA Pediatric Committee on the Pediatric Investigation Plan for MaaT013.