News and Press Releases
U.S. FDA Grants Priority Review to sBLA for PADCEV + Keytruda as Perioperative Treatment for Muscle-Invasive Bladder Cancer Regardless of Cisplatin Eligibility
Submission based on statistically significant event-free and overall survival data from the Phase 3 EV-304 trial Building on the existing indication in cisplatin-ineligible muscle-invasive bladder cancer (MIBC), if approved, this...
Category: Biotechnology, Clinical Trials, Other, Pharmaceutical
Posted: April 20, 2026
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 Pharmaceuticals Headquarters Hohenrainstrasse 24 | 4133 Pratteln | Switzerland
Pharming Group announces U.S. FDA acceptance and Priority Review of supplemental New Drug Application forleniolisib in children with APDS aged 4 to 11 years
If approved, leniolisib will be first and only treatment indicated for children with activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS), a rare primary immunodeficiency Decision based on positive data from...
Category: Biotechnology, Drug Discovery, Other, Pharmaceutical
Posted: October 1, 2025
Pharming Group N.V. Vondellaan 47 2332 AA Leiden The Netherlands
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
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
Tolebrutinib regulatory submission accepted for priority review in the US for patients with multiple sclerosis
If approved, tolebrutinib would be the first and only brain-penetrant BTK inhibitor to both treat non-relapsing secondary progressive multiple sclerosis (MS) and slow disability accumulation independent of relapse activity Tolebrutinib...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: March 25, 2025
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
Santhera Receives Positive Recommendation from Scottish Medicines Consortium for the Use of AGAMREE® (Vamorolone) in Duchenne Muscular Dystrophy Patients in NHS Scotland
AGAMREE® is approved by MHRA for treating Duchenne muscular dystrophy (DMD) in patients 4 years of age and older in UK 14 January 2025 -- Pratteln, Switzerland -- Santhera Pharmaceuticals...
Category: Other, Pharmaceutical
Posted: January 14, 2025
Santhera Pharmaceuticals Headquarters Hohenrainstrasse 24 | 4133 Pratteln | Switzerland
Santhera Enters into Supply and Distribution Agreement for AGAMREE (Vamorolone) with Clinigen Group
6 January 2025 -- Pratteln, Switzerland -- Santhera Pharmaceuticals announces the signing of an exclusive agreement with Clinigen Group to manage the supply and distribution of AGAMREE (vamorolone) in countries...
Category: Logistics, Manufacturing and Packing, Other, Pharmaceutical
Posted: January 6, 2025
Santhera Pharmaceuticals Headquarters Hohenrainstrasse 24 | 4133 Pratteln | Switzerland
Santhera Announces Approval from China’s NMPA for AGAMREE® (Vamorolone) as a Treatment for Duchenne Muscular Dystrophy
China’s National Medical Products Administration (NMPA) approved AGAMREE® for the treatment of Duchenne muscular dystrophy in patients aged 4 years and older This approval makes AGAMREE the first and only...
Category: Other, Pharmaceutical
Posted: December 11, 2024
Santhera Pharmaceuticals Headquarters Hohenrainstrasse 24 | 4133 Pratteln | Switzerland
Santhera Receives Positive Recommendation from NICE for AGAMREE (Vamorolone) as a Treatment for Duchenne Muscular Dystrophy
AGAMREE® has been recommended by NICE for treating Duchenne muscular dystrophy (DMD) in patients 4 years of age and older in England, Wales and Northern Ireland Santhera will be working...
Category: Drug Discovery, Other, Pharmaceutical
Posted: December 10, 2024
Santhera Pharmaceuticals Headquarters Hohenrainstrasse 24 | 4133 Pratteln | Switzerland
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
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
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
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
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
