Bayer files for approval of finerenone in heart failure in the EU

3 February 2025 - Regulatory submission is based on positive data from the Phase 3 FINEARTS-HF study presented at ESC Congress ...

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European Commission approves Biocon Biologics’ ustekinumab biosimilar

18 February 2025 - Biocon announced today that the European Commission granted marketing authorisation in the European Union for Yesintek, ...

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Selpercatinib for the treatment of patients with advanced RET fusion positive non-small-cell lung cancer

19 February 2025 - NICE has published final evidence-based recommendations on the use of selpercatinib (Retsevmo) for the treatment of ...

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Durvalumab in combination with etoposide phosphate and either carboplatin or cisplatin for the first-line treatment of patients with extensive-stage small-cell lung cancer

19 February 2025 - NICE has published final evidence-based recommendations on durvalumab (Imfinzi) with etoposide and either carboplatin or cisplatin ...

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Galderma’s Nemluvio (nemolizumab) granted marketing authorisation in the United Kingdom and Switzerland for moderate to severe atopic dermatitis and prurigo nodularis

18 February 2025 - These are the first approvals of nemolizumab from countries within the Access Consortium framework, with regulatory review ...

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Ultragenyx announces FDA acceptance and priority review of the biologics license application for UX111 AAV gene therapy to treat Sanfilippo syndrome type A

18 February 2025 - FDA decision expected by 18 August 2025. ...

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Welireg (belzutifan) receives first European Commission approval for two indications

18 February 2025 - Welireg is the first and only oral hypoxia-inducible factor-2 alpha inhibitor approved in the European Union ...

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Petosemtamab granted breakthrough therapy designation by the US FDA for first-line PD-L1 positive head and neck squamous cell carcinoma

18 February 2025 - This marks the second breakthrough therapy designation for petosemtamab in head and neck squamous cell carcinoma. ...

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US FDA accepts Gilead’s new drug applications for twice yearly lenacapavir for HIV prevention under priority review

18 February 2025 - FDA to review applications under priority review, with a PDUFA date of 19 June 2025. ...

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Chimerix announces FDA acceptance and priority review of new drug application for dordaviprone as treatment for recurrent H3 K27M mutant diffuse glioma

18 February 2025 - PDUFA target action date of 18 August 2025. ...

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Novartis’ Kisqali granted MHRA approval to treat early breast cancer patients

5 February 2025 - The medicine is already approved in the UK to treat advanced cases of the disease. ...

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Dupixent (dupilumab) sBLA accepted for FDA priority review for the targeted treatment of bullous pemphigoid

18 February 2025 - If approved, Dupixent would be the first and only targeted medicine to treat bullous pemphigoid in the US; ...

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Nemolizumab approved to treat prurigo nodularis and atopic dermatitis for patients in the UK

17 February 2025 - This national approval was granted after an Access Consortium new active substance work-sharing initiative (NASWSI) procedure. ...

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Rznomics liver cancer drug candidate secures fast track designation

17 February 2025 - Second fast track designation following brain cancer approval. ...

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Platform clinical trials for the efficient evaluation of multiple treatments

17 February 2025 - For some medical conditions, including conditions without effective treatments, multiple promising but unproven therapies may exist, with ...

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We could be paying too much for knee and hip replacements

18 February 2025 - As more baby boomers have their joints replaced and the population struggles with obesity, we need to ...

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