Pharmafile Logo

News and Press Releases

Formycon receives FDA approval for FYB203/ AHZANTIVE) (aflibercept-mrbb), a biosimilar to Eylea

1 July 2024, Planegg-Martinsried, Germany - Formycon AG (FSE: FYB, “Formycon”) and its licencing partnerKlinge Biopharma GmbH ("Klinge") jointly announce that the U.S. Food and Drug Administration ("FDA")approved FYB203/AHZANTIVE (aflibercept-mrbb),...

Category: Pharmaceutical
Posted: July 1, 2024

Formycon
inof@formycon.com
Formycon AG, Fraunhoferstraße 15, 82152 Martinsried/Planegg, Germany

CHMP adopts positive opinion for BALVERSA (erdafitinib) for the treatment of adult patients with unresectable or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations

Pending approval, erdafitinib would become the first therapy targeting FGFR3 alterations in patients with metastatic urothelial carcinoma, one of Europe’s most common cancers The CHMP’s recommendation is based on results...

Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: June 28, 2024

Johnson & Johnson Innovative Medicine
mediaenquiries@its.jnj.com
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG

Enterprise Therapeutics appoints Dr Renu Gupta as chief medical officer and Dr Janet Hammond as non-executive director

Appointments bring additional respiratory and late clinical-stage drug development experience as company commences Phase 2a clinical trial of its lead asset 17 June 2024, Brighton, UK -: Enterprise Therapeutics Ltd...

Category: Biotechnology, Pharmaceutical
Posted: June 17, 2024

Enterprise Therapeutics
info@enterprisetherapeutics.com
Sussex Innovation Centre, University of Sussex, Science Park Square, Falmer, Brighton, BN1 9SB, UK

Tapinarof may mark Dermavant’s first atopic dermatitis approval, says GlobalData

Dermavant's VTAMA (tapinarof), a nonsteroidal, topical AhR-modulating agent, achieved positive phase 3 trial results in atopic dermatitis patients aged two and above, leading to Food and Drug Administration (FDA) acceptance...

Category: Drug Discovery, Pharmaceutical
Posted: June 13, 2024

GlobalData
GlobalData, John Carpenter House, 7 Carmelite Street, London, EC4Y 0BS, United Kingdom

Enterprise Therapeutics publishes preclinical profile of ETD001, a novel inhaled ENaC blocker

Low doses of ETD001 demonstrate exceptionally long duration of action in sheep model of airway mucus clearance Report in Journal of Cystic Fibrosis discloses best-in-class profile of ETD001 ETD001 scheduled...

Category: Biotechnology, Clinical Trials, Drug Delivery, Drug Discovery, Pharmaceutical
Posted: June 12, 2024

Enterprise Therapeutics
info@enterprisetherapeutics.com
Sussex Innovation Centre, University of Sussex, Science Park Square, Falmer, Brighton, BN1 9SB, UK

Medicines and Healthcare Products Regulatory Agencyauthorises GSK’s Omjjara (momelotinib) in Great Britainfor treating splenomegaly or symptoms in adultmyelofibrosis patients with moderate to severe anaemia

First JAK inhibitor treatment in Great Britain specifically indicated for both newly diagnosed and previously treated myelofibrosis patients with moderate to severe anaemia 31 January 2024 -- Middlesex, UK --...

Category: Pharmaceutical
Posted: January 31, 2024

GSK
980 Great West Rd, London TW8 9GS