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News and Press Releases

Santhera Announces Approval in Canada for AGAMREE (Vamorolone) as a Treatment for Duchenne Muscular Dystrophy

Health Canada approved AGAMREE for the treatment of Duchenne muscular dystrophy in patients aged 4 years and older This approval makes AGAMREE the first and only approved therapy for DMD...

Category: Other, Pharmaceutical
Posted: October 3, 2025

Santhera
office@santhera.com
Santhera Pharmaceuticals Headquarters Hohenrainstrasse 24 | 4133 Pratteln | Switzerland

European Commission approves Johnson & Johnson’s subcutaneous DARZALEX (daratumumab)-based quadruplet regimen for the treatment of patients with newly diagnosed multiple myeloma, regardless of transplant eligibility

Approval cements daratumumab as a foundational therapy in newly diagnosed multiple myeloma and the only anti-CD38 antibody for all patient types in this setting  Phase 3 CEPHEUS study shows significant...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: April 7, 2025

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

Vertex Announces UK MHRA Approval of ALYFTREK (Deutivacaftor/Tezacaftor/Vanzacaftor), a Once-Daily Next-in-Class CFTR Modulatorfor the Treatment of Cystic Fibrosis

Deutivacaftor/tezacaftor/vanzacaftor approved for people with cystic fibrosis 6 years and older with at least one responsive mutation in the CFTR gene, including additional mutations not previously approved with other CFTR...

Category: Drug Discovery, Other, Pharmaceutical
Posted: March 7, 2025

Vertex Pharmaceuticals

CHMP recommends RYBREVANT®▼ (amivantamab) in combination with LAZCLUZE®▼ (lazertinib) for the first-line treatment of patients with EGFR-mutated advanced non-small cell lung cancer

The amivantamab plus lazertinib combination regimen offers potential to provide new standard of care as first-line option for adult patients with advanced NSCLC with EGFR ex19del or L858R substitution mutations...

Category: Clinical Trials
Posted: November 20, 2024

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

Pierre Fabre Laboratories receives European Commission Approval for BRAFTOVI® (encorafenib) in combination with MEKTOVI® (binimetinib) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with a BRAFV600E mutation

Castres, France, August 30, 2024 – Pierre Fabre Laboratories announced today that the European Commission (EC) has approved BRAFTOVI® (encorafenib) in combination with MEKTOVI® (binimetinib) for the treatment of adult...

Category:
Posted: September 5, 2024

Pierre Fabre Laboratories
laurence.marchal@pierre-fabre.com
1 Avenue d'Albi, Castres, Occitanie 81100, Tarn, France.

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

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