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FDA grants leukaemia drug ‘breakthrough’ status

FDA grants leukaemia drug ‘breakthrough’ status

A leukaemia drug has been granted ‘breakthrough therapy’ status by the US drug regulator. Daiichi Sankyo announced that

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FDA grants leukaemia drug ‘breakthrough’ status

https://pharmaphorum.com/market-access-2/fda-grants-leukaemia-drug-breakthrough-status/

Indivior’s once-monthly schizophrenia injection gets US green light

Indivior’s once-monthly schizophrenia injection gets US green light

Regulators authorities in the US have approved Indivior’s long-acting injectable treatment for adults with schizophrenia. Perseris (risperidone) won

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Indivior’s once-monthly schizophrenia injection gets US green light

https://pharmaphorum.com/news/indivior-schizophrenia-perseris-fda/

FDA refuses to approve Insys opioid painkiller

FDA refuses to approve Insys opioid painkiller

The US regulators have rejected Insys Therapeutics’ opioid-based painkiller because of concerns about its safety. The FDA knock-back

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FDA refuses to approve Insys opioid painkiller

https://pharmaphorum.com/news/fda-insys-therapeutics-opioid-painkiller/

Bayer hits back at Netflix medical device documentary

Bayer hits back at Netflix medical device documentary

Bayer has issued a robust defence of Essure after the birth control implant was featured in The Bleeding

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Bayer hits back at Netflix medical device documentary

https://pharmaphorum.com/news/bayer-netflix-essure-safety/

FDA releases Biosimilar Action Plan: Hear more at Biosimilars USA conference

FDA releases Biosimilar Action Plan: Hear more at Biosimilars USA conference

Biosimilars USA conference information

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FDA releases Biosimilar Action Plan: Hear more at Biosimilars USA conference

https://pharmaphorum.com/partner-content/fda-releases-biosimilar-action-plan-hear-more-at-biosimilars-usa-conference/

Lyophilization USA

Lyophilization USA

SMi 4th annual Conference Lyophilization USA November 15 – 16, 2018 New Jersey, USA http://www.lyophilization-usa.com/pharmaphorumWL Lyophilization is

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Lyophilization USA

https://pharmaphorum.com/events/lyophilization-usa/

FDA approves Janssen’s HIV combination Symtuza

FDA approves Janssen’s HIV combination Symtuza

Janssen has won US approval for its once-daily HIV pill Symtuza (D/C/F/TAF), which it hopes will improve patient

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FDA approves Janssen’s HIV combination Symtuza

https://pharmaphorum.com/news/fda-janssen-hiv-symtuza/

FDA approves the first smallpox treatment

FDA approves the first smallpox treatment

Siga Technologies has won US approval for Tpoxx, the first drug to be licensed to treat smallpox which, despite

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FDA approves the first smallpox treatment

https://pharmaphorum.com/news/fda-smallpox-tpoxx-siga-technologies/

Amgen and UCB re-file Evenity for US approval

Amgen and UCB re-file Evenity for US approval

Amgen and UCB have resubmitted their application for US approval of Evenity as an osteoporosis treatment, hoping that

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Amgen and UCB re-file Evenity for US approval

https://pharmaphorum.com/news/amgen-ucb-evenity-fda-filing/

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