FDA grants accelerated approval to retifanlimab-dlwr for metastatic or recurrent locally advanced Merkel cell carcinoma

22 March 2023 - Today the FDA granted accelerated approval to retifanlimab-dlwr (Zynyz, Incyte) for adult patients with metastatic or ...

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AbbVie provides regulatory update on ABBV-951 (foscarbidopa/foslevodopa) new drug application

22 March 2023 - AbbVie today announced it received a complete response letter from the US FDA for the new ...

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Advancing regulatory science in the EU – mid-point report published

22 March 2023 - The EMA has published a report summarising the mid-term achievements of its regulatory science strategy to ...

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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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Dupixent (dupilumab) approved by European Commission as first and only targeted medicine for children as young as six months old with severe atopic dermatitis

21 March 2023 - Milestone marks third Dupixent European Commission approval in the past four months. ...

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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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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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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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