FDA approves first in class Evkeeza (evinacumab-dgnb) for young children with ultra rare form of high cholesterol

22 March 2023 - Approval extends Evkeeza to children aged 5 to 11 with homozygous familial hypercholesterolaemia, an inherited condition characterised ...

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Drug repurposing during the COVID-19 pandemic: lessons for expediting drug development and access

20 March 2023 - The COVID-19 pandemic created a large, sudden unmet public health need for rapid access to safe and ...

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Sandoz receives US FDA approval for biosimilar Hyrimoz (adalimumab-adaz) high concentration formulation

21 March 2023 - Biosimilar Hyrimoz (adalimumab-adaz) high-concentration formulation approved for seven indications of reference medicine Humira. ...

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Techdow USA announces FDA approval of generic Lovenox (enoxaparin sodium – preservative free) in pre-filled syringes

20 March 2023 - Techdow today announced the FDA approval of enoxaparin sodium (preservative free) in pre-filled syringes for the US ...

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Moderna expects to price its COVID vaccine at about $130 in the US

20 March 2023 - Moderna expects to price its COVID-19 vaccine at around $130 per dose in the US going ...

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Top FDA official: agency needs to start using accelerated approval for gene therapies

20 March 2023 - A top FDA official said Monday that the agency needs to start using accelerated approval, a ...

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Prestige Biopharma receives FDA fast track designation for PBP1510 in the treatment of pancreatic cancer

21 March 2023 - Prestige Biopharma has received fast track designation from the US FDA for PBP1510 (ulenistamab), in the ...

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Diabetes treatment can be incredibly costly. But the biggest cost is (surprisingly) not insulin.

19 March 2023 - Millions of Americans with diabetes have cheered as drug makers slashed the price of insulin, the ...

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Opioid settlement hinders patients’ access to a wide array of drugs

13 March 2023 - An agreement between attorneys general and major drug distributors increased scrutiny on medications for ADHD, addiction, anxiety ...

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Arrowhead receives FDA fast track designation for ARO-APOC3

20 March 2023 - Arrowhead Pharmaceuticals today announced the US FDA has granted fast track designation to ARO-APOC3 for reducing ...

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Deciphera Pharmaceuticals announces FDA grants breakthrough therapy designation for Qinlock in second-line GIST patients with mutations in KIT exon 11 and 17/18

14 March 2023 - Breakthrough therapy designation is based on results from ctDNA analysis of INTRIGUE Phase 3 clinical trial demonstrating ...

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Prestige Biopharma's pancreatic cancer drug candidate put on FDA fast track

17 March 2023 - Prestige Biopharma said on Thursday that its new pancreatic cancer antibody drug candidate, PBP1510, (ulenistamab), was ...

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FDA approves dabrafenib with trametinib for paediatric patients with low grade glioma with a BRAF V600E mutation

16 March 2023 - Today, the FDA approved dabrafenib (Tafinlar, Novartis) with trametinib (Mekinist, Novartis) for paediatric patients 1 year ...

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First drugs facing Medicare price penalty are named

15 March 2023 - US lists 27 medications whose prices rose faster than inflation, triggering rebates under new law. ...

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Sanofi cuts US list price of Lantus, its most prescribed insulin, by 78% and caps out of pocket Lantus costs at $35 for all patients with commercial insurance

16 March 2023 - Sanofi announces that it will cut the list price of Lantus (insulin glargine injection) 100 units/mL, ...

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