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FDA approval

This page shows the latest FDA approval news and features for those working in and with pharma, biotech and healthcare.

Pfizer gets Array deal payoff as FDA approves Braftovi

Pfizer gets Array deal payoff as FDA approves Braftovi

Drug is second-line treatment for colorectal cancer. Pfizer’s run of approvals for new targeted cancer drugs has continued with an FDA approval for Braftovi alongside Eli Lilly’s Erbitux ... The FDA approval is based on the results of the phase 3

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  • Amarin shares tumble following Vascepa patent loss Amarin shares tumble following Vascepa patent loss

    is approved by FDA, prevent launch of generic versions of Vascepa,” said John Thero, CEO of Amarin. ... Dr Reddy’s Laboratories and Hikma Pharmaceuticals are already queueing up to launch generic versions of Vascepa, with Hikma reporting that it is

  • Bayer gets EU nod for prostate cancer drug Nubeqa Bayer gets EU nod for prostate cancer drug Nubeqa

    The EU approval comes almost eight months after the US Food and Drug Administration (FDA) approved the therapy, also under the Nubeqa brand name. ... The FDA approval came three months ahead of the expected deadline, and was based on the same study

  • Trump calls on FDA to cut ‘red tape’ as coronavirus drug trials gather pace Trump calls on FDA to cut ‘red tape’ as coronavirus drug trials gather pace

    A number of candidates begin trial testing. President Donald Trump has asked the FDA to remove barriers to getting coronavirus therapeutics to patients, as the US government updated on progress with ... Trump wants the FDA to speed up approval of new

  • FDA knocks back DBV’s peanut allergy therapy once again FDA knocks back DBV’s peanut allergy therapy once again

    Drug loses further ground to Aimmune's Palforzia. DBV Technologies’ struggle to get its peanut allergy therapy approved looks set to drag on, after the US Food and Drug Administration (FDA) ... France-based DBV filed for approval of Viaskin Peanut at

  • EU grants approval for Venclyxto/Gazyvaro combo in CLL EU grants approval for Venclyxto/Gazyvaro combo in CLL

    expanded. It’s a fillip for both AbbVie and Roche after venetoclax missed the mark in a confirmatory trial in acute myeloid leukaemia (AML) earlier this month, placing its conditional approval ... The latest green light is based on the CLL14 trial,

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