The National Institute for Health and Care Excellence (NICE) has recommended the first bispecific antibody for the treatment of follicular lymphoma (FL). Tepkinly (epcoritamab), developed by biopharmaceutical company AbbVie, has been recommended to the NHS as an option to treat adult patients with FL whose cancer has returned… Read More
The US Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) for a drug desensitising highly sensitised adult kidney transplant patients. Imlifidase, developed by biopharmaceutical company Hansa Pharma, is a unique IgG cleaving enzyme that rapidly inactivates over 95% of donor–specific antibodies within two to… Read More
The European Innovation Council (EIC) has awarded €2.5 million to biotechnology company Step Pharma to accelerate the development of dencatistat for CTPS2 null gynaecological tumours. The funding, which consists of a €2.5 million grant and potentially up to €10 million in equity investment, is part of the EIC’s Accelerator Award,… Read More
The European Commission (EC) has approved a higher dosage of obesity drug Wegovy which has proved it can help adults lose weight more effectively. Final approval has been granted to a new 7.2mg once-weekly maintenance dose of Wegovy (semaglutide injection), giving doctors another treatment option alongside the previous 2.4mg… Read More
The Association of the British Pharmaceutical Industry (ABPI) has urged scientists to develop better pre-clinical models to accelerate the development of new medicines. The ABPI, in collaboration with the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs), has published a landmark review examining the… Read More
The US Senate has reauthorised the US Food and Drug Administration (FDA)’s Priority Review Voucher (PRV), helping biotech companies to develop rare disease drugs. The PRV programme, which incentivises rare disease drug development, was reauthorised on 30 January, with President Donald Trump signing the bill. … Read More
UCB’s Kygevvi (doxecitine and doxribtimine) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending marketing authorisation under exceptional circumstances. The recommendation is for the treatment of paediatric and adult patients with genetically confirmed thymidine kinase… Read More
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Zynyz (retifanlimab) in combination with carboplatin and paclitaxel (platinum-based chemotherapy). If it is approved by the European Commission it will be the first… Read More
The US Food and Drug Administration (FDA) has placed a clinical hold on REGENXBIO’s investigational gene therapy, RGX-111, for the treatment of MPS I, following a single case of neoplasm (intraventricular CNS tumour) in a participant treated in its Phase I/II study. The FDA also placed a… Read More
Johnson & Johnson’s Akeega (niraparib and abiraterone acetate dual action tablet) could soon be available to EU patients with metastatic hormone-sensitive prostate cancer with BRCA1/2 mutations, following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP). The recommendation is for niraparib and abiraterone… Read More
The US Food and Drug Administration (FDA) has cleared Siren Biotechnology’s first Investigational New Drug (IND) application for its AAV immuno-gene therapy for cancer, enabling the initiation of its first-in-human clinical trial. The IND clearance supports the evaluation of Siren’s lead investigational programme in adult patients with… Read More
The European Commission (EC) has approved a respiratory syncytial virus (RSV) vaccine for the treatment of adult patients with lower respiratory tract disease (LRTD) caused by RSV. Arexy, an adjuvanted recombinant RSV vaccine developed by GSK, will now be available to adult patients in European countries. The… Read More
The US Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application for a registration Phase III trial of iSCIB1+ Immunobody in advanced melanoma. The application, submitted by biotechnology company Scancell Holdings, has been cleared with progression free survival as the agreed surrogate endpoint. Scancell has completed the 140-patient… Read More
Biopharmaceutical company BioXcel Therapeutics has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for agitation treatment Igalmi. Igalmi (dexmedetomidine) is a prescription medicine used for the acute treatment of agitation associated with schizophrenia and bipolar disorder I and II in adults. In April 2022, Igalmi was… Read More
The US Food and Drug Administration (FDA) has granted orphan drug designation to a treatment for methylmalonic acidaemia (MMA). GENE202, developed by biotechnology company Genespire, is an in vivo off-the-shelf gene therapy which harnesses the company’s Immune Shielded Lentiviral Vector (ISLV) platform to treat paediatric patients affected by genetic diseases. Read More
In 2025, the European Medicines Agency (EMA) recommended 104 medicines for marketing authorisation, 38 of which had a new active substance which had never been authorised in the European Union (EU) before. These included the first medicine to treat non-cystic fibrosis bronchiectasis, a first-in-class treatment to delay… Read More
