FDA withdraws accelerated approval to infigratinib for metastatic cholangiocarcinoma

16 May 2024 - Today, the FDA announced the final withdrawal of the approval of infigratinib (Truseltiq) for previously treated, ...

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HLB shares plummet following FDA rejection of liver cancer drug approval

17 May 2024 - HLB revealed that its US subsidiary, Elevar Therapeutics, and their Chinese partner, Jiangsu Hengrui Pharmaceuticals, received ...

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Chemists to lose dollar discount option as government bows to Pharmacy Guild pressure

16 May 2024 - Chemist Warehouse will be stripped of its ability to give its customers $1 off their medicines, ...

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Nuvalent receives US FDA breakthrough therapy designation for NVL-655

16 May 2024 - Nuvalent today announced that the US FDA has granted breakthrough therapy designation to NVL-655 for the ...

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Delegation from Taiwan visits IQWiG

15 May 2024 - At the end of April 2024, Mao-Ting Sheen visited the Institute for Quality and Efficiency in Healthcare ...

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As childhood asthma worsens, insurers restrict access to an essential medication

16 May 2024 - As paediatricians who take care of children in the inpatient, emergency, and primary care settings, we ...

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FDA grants accelerated approval to tarlatamab-dlle for extensive stage small cell lung cancer

16 May 2024 - Today, the FDA granted accelerated approval to tarlatamab-dlle (Imdelltra, Amgen) for extensive stage small cell lung ...

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Acceptability of using real world data to estimate relative treatment effects in health technology assessments: barriers and future steps

15 May 2024 - Evidence about the comparative effects of new treatments is typically collected in randomised controlled trials (RCTs). In ...

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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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It is time to reconsider the 3% discount rate

15 May 2024 - Health technology assessment guidance often recommends a 3% real annual discount rate, the appropriateness of which ...

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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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Ascendis Pharma announces extension of US FDA review period for TransCon PTH for adults with hypoparathyroidism

14 May 2024 - PDUFA goal date extended by three months for further review of submission to 14 August 2024. ...

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Eisai initiates rolling biologics license application to US FDA for Leqembi (lecanemab-irmb) for subcutaneous maintenance dosing

15 May 2024 - BioArctic's partner Eisai announced today that they have initiated the rolling submission of a biologics license application ...

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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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