regulatory approval

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FDA clears J&J's 2-in-1 tablet for prostate cancer

Johnson & Johnson has been given FDA approval for Akeega, a combination tablet for first-line treatment of adults with BRCA-positive metastatic castration-resistant pr

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J&J bags first FDA approval for a GPRC5D drug

Johnson & Johnson has become the first drugmaker to get FDA approval for a drug targeting GPRC5D, getting the nod for its bispecific antibody Talvey for a group of pat

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Astellas' Iveric takeover rewarded with FDA nod for GA drug

The FDA has approved a new drug for sight-robbing disease geographic atrophy from Astellas, just a few weeks after the company

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Zuranolone cleared for post-partum depression, but not MDD

Biogen and Sage Therapeutics' zuranolone has become the first oral drug to be approved by the FDA for post-partum depression (PPD), but the US regulator turned down a requ

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Jemperli cleared for frontline use in endometrial cancer

GSK has claimed US approval for Jemperli alongside chemotherapy for previously untreated, primary advanced or recurrent endometrial cancer, becoming the first immunotherap

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Soliris becomes first drug for paediatric gMG in Europe

AstraZeneca's Soliris has become the first approved treatment in the EU for children and adolescents with generalised myasthenia gravis, a disorder that causes weakness in

FDA clears J&J's 2-in-1 tablet for prostate cancer

J&J bags first FDA approval for a GPRC5D drug

Astellas' Iveric takeover rewarded with FDA nod for GA drug

Zuranolone cleared for post-partum depression, but not MDD

Jemperli cleared for frontline use in endometrial cancer

Soliris becomes first drug for paediatric gMG in Europe

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regulatory approval

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