ExCellThera’s Zemcelpro scores big in Germany, paving way for early hospital access

The therapy, also known as UM171 Cell Therapy, recently received conditional marketing authorization from the European Commission

Moderna’s new Covid vaccine mNEXSPIKE wins European approval

mNEXSPIKE is the third Moderna vaccine authorized in the European Union, strengthening the Company's respiratory vaccine portfolio in Europe

STADA & Bio-Thera bag European nod for Gotenfia

Amgen scores EU nod for UPLIZNA in rare autoimmune disease

The approval marks a major advance in targeted treatment for this rare, chronic autoimmune disease, offering twice-yearly maintenance dosing after two initial loading doses

Richter’s FYLREVY to transform menopause care in Europe?

The recommendation covers FYLREVY 14.2 mg and 18.9 mg for non-hysterectomised postmenopausal women experiencing oestrogen deficiency symptoms at least 12 months after their last menses

Vetter to invest €480 million in major German manufacturing expansion, eyes 2,000 jobs

The state-of-the-art commercial production plant will be built on a 95-acre site in Saarlouis, acquired at the end of 2024

Ionis and Otsuka score EU nod for DAWNZERA, offering new hope for rare HAE patients

The EU approval of DAWNZERA is an important milestone that reflects our ongoing commitment to bring this innovative medicine to people in need across the globe

EU green light to IntraBio’s AQNEURSA for rare neurological disease Niemann-Pick Type C

The approval is grounded in data from a Phase III randomized, double-blind, placebo-controlled, crossover study in NPC patients

AGC Biologics powers commercial launch of its life-changing gene therapy for rare childhood immune disorder

Waskyra is an ex vivo gene therapy that uses patients’ own CD34+ hematopoietic stem and progenitor cells, genetically engineered with a lentiviral vector

EU clears Eylea 8 mg for retinal vein occlusion, expanding use of long-acting eye therapy

Treatment typically requires frequent injections directly into the eye—an ongoing burden for patients and health systems alike