Tricida announces FDA acceptance of new drug application for veverimer

14 November 2019 - Tricida announced today that the U.S. FDA has accepted for review its new drug application for ...

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CHMP recommends EU approval of Roche’s Kadcyla for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neo-adjuvant treatment

15 November 2019 - Kadcyla cut the risk of disease recurrence or death by half compared to Herceptin in the adjuvant ...

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CHMP recommends conditional EU approval of Roche’s Polivy for people with previously treated aggressive lymphoma

15 November 2019 - First-in-class antibody-drug conjugate that specifically targets CD79b, a protein expressed in the majority of B-cells. ...

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Labour will exclude the NHS and medicines from trade deals with the US

17 November 2019 - Donald Trump wants the big US pharmaceutical companies to get its hands on our public services – ...

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Booker and Sanders propose a new federal agency to set drug prices

15 November 2019 - Senators Cory Booker and Bernie Sanders are pushing for the creation of a new federal agency ...

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PBAC Public Summary Documents - July 2019 meeting

15 November 2019 - The Public Summary Documents (first time rejections and deferrals) from the July 2019 PBAC meeting are now ...

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Novartis receives positive CHMP opinion for Mayzent (siponimod) for the treatment of adult patients with active secondary progressive multiple sclerosis

15 November 2019 - If approved, Mayzent (siponimod) will be the first and only oral treatment specifically indicated for patients ...

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Highlights from the CHMP 11-14 November 2019 meeting

15 November 2019 - Seven new medicines recommended for approval. ...

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Dutch authorities hand over final building to EMA in Amsterdam

15 November 2019 - Today, the Dutch authorities have handed over to EMA its newly built tailor-made premises, located in ...

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FDA approves first targeted therapy to treat patients with painful complication of sickle cell disease

15 November 2019 - Today, the U.S. FDA approved Adakveo (crizanlizumab-tmca), a treatment to reduce the frequency of vaso-occlusive crisis – ...

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Valeo Pharma announces filing of a new drug submission for low molecular weight heparin in Canada

14 November 2019 - Valeo Pharma announced today that the new drug submission filed for a low molecular weight heparin ...

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PHARMAC backs down on epilepsy drug brand switch

15 November 2019 - PHARMAC has backed down on a controversial drug brand switch affecting patients with epilepsy and mental ...

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PHARMAC to widen access to the exceptional circumstances process for lamotrigine

15 November 2019 - Patients taking lamotrigine who have concerns about the change can talk with their doctor about remaining ...

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FDA approves new antibacterial drug to treat complicated urinary tract infections as part of ongoing efforts to address antimicrobial resistance

14 November 2019 - The U.S. FDA today approved Fetroja (cefiderocol), an antibacterial drug for treatment of patients 18 years of ...

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FDA approves therapy to treat patients with relapsed and refractory mantle cell lymphoma supported by clinical trial results showing high response rate of tumour shrinkage

14 November 2019 - Today, the U.S. FDA granted accelerated approval to Brukinsa (zanubrutinib) capsules for the treatment of adult patients ...

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