Selinexor in combination with bortezomib and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma (final guidance)

15 May 2024 - NICE has published final evidence-based recommendations on the use of selinexor (Nexpovio) in combination with bortezomib ...

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Dynavax provides regulatory update on sBLA for four dose Heplisav-B regimen for adults on haemodialysis in the US

14 May 2024 - Dynavax Technologies today provided a regulatory update for the Company's supplemental biologics license application to include ...

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Atogepant monohydrate for the prevention of migraine

15 May 2024 - NICE has published final evidence-based recommendations on atogepant monohydrate (Aquipta) for preventing migraine in adults. ...

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ViiV Healthcare announces Health Canada approval for Apretude (cabotegravir tablets and extended release injectable suspension) for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV

13 May 2024 - The latest Canadian surveillance data shows that there were 1,833 new HIV diagnoses in 2022, a ...

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Baxter secures FDA approval of Clinolipid (lipid injectable emulsion) neonatal and paediatric indication

13 May 2024 - Expanded indication demonstrates Baxter’s continued commitment to meeting the diverse nutritional needs of patients, from preterm neonates ...

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Institute for Clinical and Economic Review publishes evidence report on treatment for post-traumatic stress disorder

14 May 2024 - There are substantial uncertainties around the clinical trial results; given the inability to assess net benefit, ...

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FDA approves updated Altuviiio label with expanded paediatric data confirming highly effective bleed protection in children with haemophilia A

10 May 2024 - Full results from the pivotal XTEND-Kids study added to the US label, building on the interim data ...

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SMC - May 2024 decisions

13 May 2024 - The SMC has today published advice on two medicines. ...

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Zai Lab announces approval of Augtyro (repotrectinib) for patients with ROS1 positive NSCLC by China’s NMPA

12 May 2024 - The approval is based on the pivotal TRIDENT-1 trial, in which Augtyro achieved a high response ...

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Remdesivir and the combination of tixagevimab and cilgavimab for the treatment of patients with COVID-19 disease (final guidance)

8 May 2024 - NICE has published final evidence-based recommendations on the use of remdesivir (Veklury) and tixagevimab and cilgavimab ...

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Health Canada approves Keytruda for adult patients with locally advanced unresectable or metastatic biliary tract carcinoma, in combination with gemcitabine-based chemotherapy

9 May 2024 - Approval is based on the Phase 3 KEYNOTE-966 Trial. ...

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Qulipta (atogepant) now approved by Health Canada for the preventive treatment of chronic migraine in adults

8 May 2024 - Approval was based on a pivotal Phase 3 clinical trial that demonstrated statistically significant reduction from baseline ...

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Aspaveli (pegcetacoplan) approved in Europe for use among treatment naïve adult patients with PNH

8 May 2024 - Sobi today announced that the European Commission has approved an indication extension for Aspaveli (pegcetacoplan) for ...

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Health Canada approves Zoladex LA for the management of oestrogen receptor positive early breast cancer with a high risk of recurrence or advanced breast cancer in pre- and peri-menopausal women

7 May 2024 - TerSera Canada today announced that Health Canada has approved a supplemental new drug submission for Zoladex LA ...

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Selinexor with dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma after 4 or more treatments

8 May 2024 - NICE has published evidence-based recommendations on the use of selinexor (Nexpovio) in combination with dexamethasone for ...

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