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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.
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Regs & Legs
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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.
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Italian non-profit set for European gene therapy first in Wiskott-Aldrich syndrome
Fondazione Telethon’s Waskyra (etuvetidigene autotemcel) has been recommended for approval by the CHMP as a treatment for the rare disease.
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FDA hits Sarepta with liver warning labelling for its DMD drug Elevidys
As well as the new safety warnings for the Duchenne muscular dystrophy gene therapy, the biopharma company also faced a new, more restrictive licence for the treatment.
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MHRA approves Leqembi IV maintenance as additional Alzheimer’s option
Decision provides UK Alzheimer’s patients with an alternative administration method for Eisai and Biogen’s antibody drug.
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FDA names Dr Richard Pazdur to replace George Tidmarsh as CDER Director
The FDA-veteran and oncology specialist will lead the US drug agency’s work ensuring the safety and efficacy of medicines.
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MHRA selects Prof Jacob George as its first Chief Medical and Scientific Officer
The cardiovascular expert will head the UK medicines regulator’s science and innovation strategies.
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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.
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FDA draft guidance on biosimilars offers “regulatory relief”
US agency follows in footsteps of European Medicines Agency (EMA) in efforts to streamline biosimilar development.
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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.
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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.
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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.
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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.
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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.
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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.
