Bernie Sanders wants to rein in drug prices. Is he asking the right questions?

28 February 2024 - We have a serious problem of affordability of health care in the US, including the cost of ...

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Applied Therapeutics announces FDA acceptance and priority review of new drug application for govorestat for the treatment of classic galactosaemia

28 February 2024 - PDUFA target action date of 28 August 2024. ...

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Incyte announces US FDA grants priority review for axatilimab for the treatment of chronic graft versus host disease

27 February 2024 - Priority review acceptance based on positive results of AGAVE-201 study. ...

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The FDA isn’t afraid to yank a disappointing drug

26 February 2024 - The FDA is rescinding its approval of a blood cancer treatment from the Swedish firm Oncopeptides, ...

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FDA grants fast track designation to 9MW2821

27 February 2024 - Mabwell announces that its self developed novel antibody drug conjugate targeting Nectin-4 (9MW2821) has been granted fast ...

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Nuvalent receives US FDA breakthrough therapy designation for NVL-520

27 February 2024 - Nuvalent today announced that the US FDA has granted breakthrough therapy designation to NVL-520 for the ...

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Theratechnologies receives refusal to file letter for Trogarzo intramuscular method of administration sBLA from FDA

27 February 2024 - Theratechnologies today announced that the US FDA has issued a refusal to file letter regarding the Company’s ...

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BeiGene’s biologics license application for Tevimbra (tislelizumab) for first-line gastric or gastro-oesophageal junction cancers accepted by FDA

27 February 2024 - Application based on results from global Phase 3 RATIONALE-305 trial demonstrating Tevimbra plus chemotherapy significantly improved overall ...

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Minerva Neurosciences receives complete response letter from FDA for new drug application for roluperidone for the treatment of negative symptoms in patients with schizophrenia

27 February 2024 - Minerva Neurosciences announced today that the US FDA has issued a complete response letter to the ...

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US FDA accepts for priority review the supplemental biologics license application for epcoritamab (Epkinly) for difficult to treat relapsed or refractory follicular lymphoma

26 February 2024 - FDA grants priority review with target action date of 28 June 2024. ...

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Bayer receives US FDA breakthrough therapy designation for BAY 2927088 for non-small-cell lung cancer harbouring HER2 activating mutations

26 February 2024 - BAY 2927088 is an oral, small molecule tyrosine kinase inhibitor under development as a potential new targeted ...

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Alvotech and Teva announce US approval of Simlandi (adalimumab-ryvk) injection, the first interchangeable high concentration, citrate free biosimilar to Humira

23 February 2024 - Simlandi is the first citrate free, high concentration biosimilar to be designated interchangeable to Humira in the ...

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Venatorx and Melinta provide update on status of US new drug application for cefepime-taniborbactam

23 February 2024 - No clinical safety or efficacy issues identified. ...

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Prices for new US drugs rose 35% in 2023, more than the previous year

23 February 2024 - Pharmaceutical companies last year launched new US drugs at prices 35% higher than in 2022, reflecting ...

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FDA issues final decision to withdraw approval of Pepaxto (melphalan flufenamide)

23 February 2024 - Today, the FDA announced its final decision to withdraw approval of Pepaxto (melphalan flufenamide), which was ...

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