news
European Commission calls for bio-based innovation in new EU Bioeconomy Strategy
Changes proposed in the EU body’s regulatory framework aim to create a competitive and sustainable European bioeconomy.
List view / Grid view
European Commission (EC)
news
Dupixent receives first-in-decade EU approval in chronic spontaneous urticaria
European approval of Sanofi and Regeneron’s monoclonal antibody provides eligible urticaria patients with a new first-line targeted treatment option.
news
First biosimilar version of J&J’s Simponi approved in Europe
Authorisation of the biosimilar Gobivaz provides a substitute biologic medicine to Simponi for individuals with immune-mediated diseases.
news
Insmed wins first EU approval for non-cystic fibrosis bronchiectasis treatment
Oral small molecule treatment Brinsupri (brensocatib) could become a new standard of care for patients with the progressive lung disease.
news
Europe unveils science strategy as it looks to become an ‘AI continent’
Establishes Resource for AI Science in Europe and eyes frontier AI models and autonomous agentic AI for pharma.
news
Lilly wins European Alzheimer’s approval for Kisunla after regulatory setbacks
The anti-amyloid monoclonal antibody is part of the class of medicines representing the first disease-modifying therapies for the neurodegenerative disease.
news
Biogen wins European first for depression drug Zurzuvae
The medicine becomes the first EU-approved oral treatment for adults who have postpartum depression (PPD).
news
Critical Medicines Act ‘must prioritise’ EU pharmaceutical manufacturing competitiveness
European Parliament's SANT Committee urges for greater control on medicine provisions to help strengthen security of supply.
news
EU Biotech Act public consultation opens for input
The European Commission hopes its planned legislation will enable biotechnology companies to bring products from laboratory to market more quickly.
news
EU and US agree preliminary tariffs deal
Marking the first step in the negotiation process, this deal establishes key parameters of the final political agreement on trade and tariffs between the EU and US.
news
Novel pre-filled autoinjector receives EU approval
The EU authorisation offers a new treatment option for acromegaly, providing effective disease control and enabling convenient self-administration.
news
Tackling EU supply chain challenges while boosting innovation
Medicines for Europe calls for continued progress of pharmaceutical reforms such as the Critical Medicines Act, to support production of essential medicines in the region.
news
European Commission Alzheimer’s drug approval marks advancement for EU patients
Lecanemab is the only approved Aβ monoclonal antibody that highly binds to and clears toxic protofibrils with high selectivity.
news
First-of-a-kind EU approval granted for oral small molecule
The authorisation provides a new disease modifying treatment option for European patients with the progressive condition.
news
CHMP meeting highlights – January 2025
In its January meeting, the EMA’s human medicines committee recommended eight new medicines, including biosimilars and a new vaccine.
