FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease

29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...

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Seikagaku announces receipt of a complete response letter concerning the biologics license application in the US for SI-6603 (condoliase)

12 March 2025 - Seikagaku announced today that it has received from the US FDA a complete response letter concerning ...

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First daily pill for endometriosis approved for NHS use

13 March 2025 - Today we've recommended the first long-term daily pill to treat endometriosis that could transform how this painful ...

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Atsena Therapeutics granted US FDA fast track designation for ATSN-201 gene therapy to treat X-linked retinoschisis

12 March 2025 - Marks third FDA designation for ATSN-201, which has also received rare paediatric disease designation and orphan drug ...

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Sydnexis announces FDA acceptance of new drug application and PDUFA date for SYD-101 for the treatment of progression of paediatric myopia

11 March 2025 - Sydnexis today announced that the US FDA has accepted its new drug application for SYD-101 and ...

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PHARMAC to fund more cancer medicines (March 2025)

12 March 2025 - PHARMAC is funding six more medicines for cancers and one for antibiotic resistant infections. ...

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Geron announces European Commission approval of Rytelo (imetelstat), a first in class telomerase inhibitor, for the treatment of adults with transfusion-dependent anaemia due to lower risk MDS

11 March 2025 - Rytelo is the first and only telomerase inhibitor approved in the US and Europe. ...

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Celltrion's infliximab, the first monoclonal antibody biosimilar, is now Remdantry in Canada

11 March 2025 - CT-P13, intravenous infliximab, developed and manufactured by Celltrion, is the first monoclonal antibody biosimilar therapy and has ...

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ACCRUFeR (ferric maltol) is now available in Canada as a prescription oral treatment for iron deficiency anaemia

11 March 2025 - ACCRUFeR is the only oral iron therapy approved as a prescription drug in Canada. ...

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Atezolizumab for the first-line treatment of adults with advanced or recurrent non-small-cell lung cancer when platinum-doublet chemotherapy is unsuitable

12 March 2025 - NICE is unable to make a recommendation on the use of atezolizumab (Tecentriq) in the NHS for ...

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Zolbetuximab in combination with chemotherapy for the first-line treatment of adults with claudin-18.2 positive, HER2 negative unresectable advanced gastric or gastro-oesophageal junction adenocarcinoma (final guidance)

12 March 2025 - NICE has published final evidence-based recommendations on the use of zolbetuximab (Vyloy) in combination with chemotherapy ...

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Natalizumab for the treatment of patients with highly active relapsing–remitting multiple sclerosis after disease-modifying therapy

12 March 2025 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...

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PHARMAC funds new oral contraceptive pill

11 March 2025 - PHARMAC has decided to fund a new progestogen only oral contraceptive pill called desogestrel (Cerazette). ...

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ICER to assess treatment for non-cystic fibrosis bronchiectasis

11 March 2025 - Report will be subject of CTAF meeting in September 2025; draft scoping document open to public ...

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Health Canada authorises Lazcluze (lazertinib) in combination with Rybrevant (amivantamab) as a first-line chemotherapy-free treatment for patients with EGFR-mutated advanced lung cancer

10 March 2025 - Phase 3 MARIPOSA study showed Lazcluze plus Rybrevant significantly improved progression-free survival, reducing the risk of ...

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SMC - March 2025 decisions

10 March 2025 - The SMC, which advises on newly licensed medicines for use by NHSScotland, has today published advice ...

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