news
MHRA set to overhaul the UK’s rare disease drug regulatory pathway
The medicines regulator will aim to take a more flexible licensing approach for the research and manufacture of rare disease therapies in the UK.
List view / Grid view
Regs & Legs
news
FDA draft guidance on biosimilars offers “regulatory relief”
US agency follows in footsteps of European Medicines Agency (EMA) in efforts to streamline biosimilar development.
news
Alexion wins EU label expansion for kinase inhibitor Koselugo
Approval provides continuity of care into adulthood for patients with neurofibromatosis type 1 (NF1) using Koselugo (selumetinib) to manage symptoms.
news
FDA to pilot faster review of generic drugs manufactured in the US
Sets bioequivalence and active pharmaceutical ingredient (API) requirements for its new ANDA prioritisation programme.
news
Boehringer’s Jascayd becomes first new IPF treatment in US for a decade
FDA approval for the idiopathic pulmonary fibrosis drug supported by the pharma company’s FIBRONEER phase III clinical trials.
news
AI adoption in life science labs faces a growing skills barrier
Pistoia Alliance survey also found that the greatest benefit for lab digitalisation has shifted from efficiency to innovation.
news
Call for greater investment and innovation from pharma to address RSV
Despite progress from AstraZeneca, Sanofi, Merck & Co, GSK and Pfizer, analysts say effective respiratory syncytial virus treatments are still needed.
news
J&J’s Tremfya secures two paediatric psoriasis approvals from FDA
The US FDA approvals make the drug the first IL-23 inhibitor to be licensed for two common skin conditions.
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
Merck & Co scores European and US wins for Keytruda
The CHMP hands the cancer drug two new recommendations, and the FDA approves its subcutaneous use as Keytruda Qlex.
news
Novo Nordisk’s once-weekly diabetes jab Kyinsu set for European approval
EMA advisors at the CHMP backed the combination treatment and also recommended Bayer’s menopause drug Lynkuet, putting both on the path to being licensed.
article
Microbiology/RMM In-Depth Focus 2025
This in-depth focus features articles on rapid microbiological methods, quality control, and using AI to read agar plates.
article
Drug development In-Depth Focus 2025
From groundbreaking cell and gene therapies to cost-effective drug delivery innovations, Europe is emerging as a hub for life-changing therapies. Explore expert insights and innovative solutions shaping the pharmaceutical industry.
article
European Pharmaceutical Review Issue 3 2025
EPR Issue 3 includes articles on microbiology, downstream processing, manufacturing, drug formulation and more.
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).
