news
Eculizumab biosimilar gets positive CHMP opinion
Samsung Bioepis’ first haematology biosimilar, which references Soliris (eculizumab), has been recommended for approval by the CHMP.
List view / Grid view
Drug Safety
news
Treatment shows strong potential for ALK-driven neuroblastoma
A Phase I study has shown significant promise in treating newly diagnosed ALK-driven high-risk neuroblastoma in paediatric patients.
news
CHMP meeting highlights – March 2023
In the European Medicines Agency's March human medicines committee meeting, nine new medicines were recommended, including one for multiple sclerosis.
news
First immunotherapy recommended for advanced cervical cancer
Final draft guidance published by the National Institute for Health and Care Excellence (NICE) has recommended immunotherapy pembrolizumab drug for advanced cervical cancer.
news
First-in-class plaque psoriasis oral therapy approved in EU
Bristol Myers Squibb’s Sotyktu is the only TYK2 inhibitor approved for the treatment of any disease in the European Union.
news
Rapid microbiology testing market growth expected 2022 to 2027
Driven partly by growth-based methods, the rapid microbiology testing market is predicted to expand considerably from 2022 to 2027, says a report.
news
Nasal spray for depression shows long-term efficacy
SPRAVATO® achieved significant long-term response rates in treatment-resistant depression, compared to quetiapine extended release, Janssen’s Phase IIIb study has shown.
news
First mild asthma combination reliever approved in UK
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the first dual-combination, inhaled corticosteroid and long-acting beta2-agonist reliever therapy for mild asthma.
article
Developing novel therapies for NASH
In this exclusive interview, Dr Hank Mansbach, Chief Medical Officer of 89bio discusses clinical development of FGF21 therapy to treat fatty liver disease.
news
Could Dupixent be the first biologic to treat COPD?
Dupixent® is the first biologic to demonstrate significant improvement in lung function compared to placebo, a pivotal Phase III trial has shown.
news
MHRA approves prostate cancer combination therapy
The first PARP inhibitor to show clinical benefit with a new hormonal agent in first-line metastatic castration-resistant prostate cancer has been granted UK approval.
news
BioNTech to jointly develop novel antibody for cancers
ONC-392, an anti-CTLA-4 monoclonal antibody for solid tumours will be jointly developed by BioNTech and biopharma OncoC4.
news
Novartis releases long-term data for SMA gene therapy
Long-term follow-up study data for Zolgensma®, Novartis’ one-time gene therapy for spinal muscular atrophy (SMA), has shown promising overall milestone achievements.
news
First FcRn blocker approved in UK for myasthenia gravis
VYVGART (efgartigimod alfa-fcab) has been approved for adults with generalised myasthenia gravis by UK Medicines and Healthcare products Regulatory Agency (MHRA).
news
Dual cystic fibrosis modulator therapy shows efficacy in four-year study
Cystic fibrosis patients can safely take a dual combination of cystic fibrosis modulator drugs for four years, a study has shown.
