Pharmafile Logo
  • - PMLiVE
  • Diversity, Equity and Inclusion
  • - PMLiVE
  • Communiqué 53 Cover Image

EMA

- PMLiVE

Roche’s Enspryng given FDA Priority Review as thyroid eye disease treatment

This is the first and only at-home subcutaneous treatment option for this disease

- PMLiVE

Regeneron’s New Drug Application for cemdisiran accepted for review by FDA and EMA

Globally, around 150 to 200 out of every million people have myasthenia gravis

- PMLiVE

Roche’s Tecentriq gets FDA Priority Review for specific stage 3 colon cancer

Over one million people are diagnosed globally each year and around 30% of stage 3 patients relapse within five years

- PMLiVE

Lilly’s Ebglyss approved by FDA as maintenance dose for atopic dermatitis

This new option for patients allows for as few as six maintenance injections per year

- PMLiVE

EMA celebrates diversity and inclusion in science and healthcare

The EU body underlines its commitment to diverse perspectives in medicines regulation

- PMLiVE

Regeneron agrees research collaboration with Parabilis Medicines

Regeneron will pay Parabilis $125m upfront, with up to $2.2bn in potential milestone payments and royalties

- PMLiVE

FDA gives Rare Paediatric Disease designation to Satellite Bio for urea cycle disorders

The mortality rates of UCDs exceeds 25%, with no curative treatment available for newborns

- PMLiVE

Astellas’ application to EMA validated for treatment of muscle-invasive bladder cancer

Bladder cancer affects over 224,000 people annually in Europe, with over 30% of cases being muscle-invasive bladder cancer

- PMLiVE

EMA’s PRIME scheme launches three major new features

The scheme supports the development of treatments targeting unmet medical needs in the EU

- PMLiVE

BMS’ Opdivo gets expanded FDA and EU approval for Hodgkin lymphoma

This type of cancer is the most common one diagnosed in teenagers

- PMLiVE

US FDA launches ultra-rare diseases framework

The draft guidance specifically discusses genome editing and RNA-based therapies

- PMLiVE

PureTech’s deupirfenidone gets FDA and EC Orphan Drug Designations for idiopathic pulmonary fibrosis

Rare diseases are defined as conditions affecting fewer than 200,000 people in the US or fewer than five in 10,000 individuals in the European Union

Subscribe to our email news alerts

Latest content

Latest intelligence

Quick links