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

CT-P59

- PMLiVE

Invivyd working with FDA towards potential Biologics License Application for COVID-19

The company plans head-to-head safety evaluation with COVID-19 vaccine, pending regulatory alignment

- PMLiVE

FDA approves Pfizer and BioNTech’s jab for COVID-19

Globally, five billion doses of the companies’ vaccine have been distributed

- PMLiVE

FDA approves Celltrion’s Actemra biosimilar Avtozma for cytokine release syndrome

Avtozma IV now fully aligns with all indications covered by Actemra IV in the US

- PMLiVE

Moderna’s LP.8.1-adapted COVID-19 vaccine recommended by CHMP

Global health authorities have recommended that vaccines for the 2025-2026 season should target LP.8.1

- PMLiVE

FDA approves new presentation of Celltrion’s SteQeyma for paediatric psoriasis

The Stelara biosimilar now offers all dosage forms and strengths of its reference product

- PMLiVE

FDA grants interchangeable designation to Celltrion’s Humira biosimilar Yuflyma

The drug is approved for inflammatory conditions such as Crohn's disease and plaque psoriasis

- PMLiVE

FDA approves Celltrion’s denosumab biosimilars Stoboclo and Osenvelt

The drugs have been authorised for all indications covered by Amgen’s bone disease therapy

- PMLiVE

EC approves Celltrion’s RoActemra biosimilar Avtozma for inflammatory diseases

The drug has been approved for rheumatoid arthritis, giant cell arteritis and other indications

- PMLiVE

EC approves CSL/Arcturus’ self-amplifying mRNA COVID-19 vaccine Kostaive

Kostaive is designed to instruct the body to make more mRNA to boost immune response

- PMLiVE

WHO urges US to ‘reconsider’ withdrawal from global health organisation

President Donald Trump said the agency mishandled the COVID-19 pandemic and other global health crises

- PMLiVE

Sanofi receives FDA fast track designation for COVID-19/flu combination vaccines

The combined vaccine approach could simplify immunisation practices and lead to higher uptake

- PMLiVE

Merck and Ridgeback initiate phase 3 study of COVID-19 oral antiviral in high-risk adults

Lagevrio is already available in the US under emergency use authorisation to treat certain cases of COVID-19

Subscribe to our email news alerts

Latest content

Latest intelligence

Quick links