Pharmafile Logo

Tofidence

- PMLiVE

Biogen’s litifilimab receives FDA Breakthrough Therapy Designation for lupus

Therapies like topical steroids manage symptoms but there is currently no cure

- PMLiVE

Eisai and Biogen’s subcutaneous Leqembi given FDA Priority Review for early Alzheimer’s

Administering the drug subcutaneously rather than intravenously showed similar clinical benefits for patients

- PMLiVE

Eisai submits new drug application for subcutaneous Leqembi in Japan

LEQEMBI is a treatment for early Alzheimer’s disease

- PMLiVE

Biogen and Eisai receive MHRA approval for updated dosing of early Alzheimer’s treatment

The MHRA approval for IV dosing comes following positive results from the global phase 3 trial

- PMLiVE

J&J’s Tremfya approved by FDA for children with plaque psoriasis and psoriatic arthritis

The drug is the first IL-23 inhibitor approved for children from the age of six

- PMLiVE

Biogen expands portfolio in deal with Alcyone Therapeutics

The agreement gives Biogen full rights to a potential therapy for patients with neurological disorders

- 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

Biogen Idec building

Biogen/Eisai’s Alzheimer’s drug Leqembi shows continued benefit over four years

An estimated 13 million people in the US will be living with Alzheimer’s disease by 2050

Biogen Idec building

Biogen’s Qalsody granted MHRA approval to treat rare form of motor neurone disease

Mutations in the SOD1 gene are responsible for approximately 2% of all cases of the disease

- 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

Subscribe to our email news alerts

Latest content

Latest intelligence

Quick links