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Home » Topics » Regulatory » EMA

EMA
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Antibody-drug conjugate

Yanked from the market in 2022, GSK’s Blenrep gets an EU redo

May 23, 2025
By Nuala Moran
No Comments
GSK plc’s Blenrep (belantamab mafodotin) is heading back to the market three years after being withdrawn, with the EMA’s Committee for Medicinal Products for Human Use recommending approval of the antibody-drug conjugate in combination therapy for the treatment of adults with relapsed or refractory multiple myeloma.
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Illustration of siRNA structure

Sirius bags $50M series B2 for cardiovascular siRNA pipeline

May 13, 2025
By Marian (YoonJee) Chu
No Comments
Sirius Therapeutics Inc. raised nearly $50 million in a series B2 financing round May 9 to support its pipeline of small interfering RNA (siRNA) molecules for cardiovascular disease indications. SRSD-107, a long-acting Factor XI anticoagulant for thromboembolic disorders, is its lead candidate waiting on EMA clearance to begin a phase II study in Europe. 
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Illustration of siRNA structure

Sirius bags $50M series B2 for cardiovascular siRNA pipeline

May 12, 2025
By Marian (YoonJee) Chu
No Comments
Sirius Therapeutics Inc. raised nearly $50 million in a series B2 financing round May 9 to support its pipeline of small interfering RNA (siRNA) molecules for cardiovascular disease indications. SRSD-107, a long-acting Factor XI anticoagulant for thromboembolic disorders, is its lead candidate waiting on EMA clearance to begin a phase II study in Europe. 
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3D illustration of a liposome
Neurology/psychiatric

Ahead Therapeutics advances myasthenia gravis program toward toxicology studies

May 9, 2025
No Comments
Ahead Therapeutics SL has received positive feedback from the EMA on its way toward initiating regulatory toxicology studies for its lead program in myasthenia gravis. The feedback supports the company’s scientific approach.
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Vyvgart Hytrulo

Argenx’s Vyvgart, Camurus’ Oczyesa among 16 recommended by CHMP

April 28, 2025
By Nuala Moran
Argenx NV is now well on the way to establishing a Vyvgart (efgartigimod alfa) franchise in severe autoimmune diseases, after getting the nod from the EMA in the treatment of progressive or relapsing chronic inflammatory demyelinating polyneuropathy.
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Illustration of kidney with DNA structures
Nephrology

Purespring’s PS-002 designated orphan drug for IgA nephropathy

April 28, 2025
The EMA has granted European orphan drug designation to Purespring Therapeutics Ltd.’s PS-002 for IgA nephropathy (IgAN).
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Human NK cell
Immuno-oncology

EMA grants IMPD approval for Emercell to study allogeneic NK cell therapy for DLBCL

April 25, 2025
Onward Therapeutics SA’s subsidiary Emercell SAS has received investigational medicinal product dossier (IMPD) approval from the EMA to initiate a phase I trial of OT-C001, an allogeneic natural killer (NK) cell therapy, in combination with an anti-CD20 monoclonal antibody, rituximab.
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Map of Europe, Medical Device Regulation (MDR) text

Elixir granted CE mark for Lithix IVL

April 15, 2025
By Annette Boyle
Receipt of EU MDR CE mark may not be a magic potion, but Elixir Medical Corp. is certainly feeling a boost from the regulatory nod for its mechanical Lithix hertz contact intravascular lithotripsy system for treatment of moderate to severely calcified coronary artery lesions. Simultaneously, the company reported the launch of Lithix and completion of first cases in Italy, France and Germany.
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Edwards Lifesciences Sapien M3

Edwards lands first CE mark for transfemoral mitral valve replacement

April 14, 2025
By Annette Boyle
Edwards Lifesciences Corp.’s Sapien M3 secured CE mark for its Sapien M3 mitral valve replacement system for transfemoral treatment of patients with mitral valve disease who are ineligible for surgery or transcatheter edge-to-edge repair. Sapien M3 is indicated for individuals with symptomatic moderate-to-severe or severe mitral valve regurgitation.
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Eye and DNA
Ocular

Variant advances ocular gene therapy VAR-002 based on feedback from EMA

April 4, 2025
Variant SAS and the Rare Ocular Diseases Center at the University of Campania Luigi Vanvitelli (UCLV) have received positive feedback from the EMA for VAR-002, a recombinant AAV vector gene therapy targeting inherited retinal dystrophies linked to CRX mutations.
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