The study found that just 20% of trials submitted to both the FDA and European Medicines Agency had matching evidence.

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 ...

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

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 ...

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

Q4 2024 Earnings Call Transcript March 5, 2025 Ocugen, Inc. reports earnings inline with expectations. Reported EPS is $-0.05 ...

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

These results of this first ever direct comparison of the gut microbiome effects of ibezapolstat in a validated humanized mouse model set the stage for potential competitive advantage of IBZ over all ...

The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended three novel medicines for approval at its February 2025 meeting. The European Commission is expected to announce a ...

Meanwhile, the European Medicines Agency (“EMA”) also validated the company’s Marketing Authorization Application (“MAA”) seeking approval for aficamten for the treatment of obstructive HCM.

CYTK reports a wider-than-expected Q4 loss as operating expenses increase. CYTK is gearing up to launch lead candidate ...

First chikungunya vaccine approved in Europe for persons as young as 12 years old.On track for launch in key European markets in the first half of 2025. COPENHAGEN, Denmark, February 28, 2025 ...