FDA approves first treatment for patients with rare inherited blood clotting disorder

9 November 2023 - Today, the US FDA approved Adzynma, the first recombinant protein product indicated for prophylactic or on demand ...

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FDA needs a competitiveness czar

15 October 2021 - The FDA needs a Deputy Commissioner for Regulatory Competitiveness.  ...

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FDA statement on following the authorised dosing schedules for COVID-19 vaccines

4 January 2021 - Two different mRNA vaccines have now shown remarkable effectiveness of about 95% in preventing COVID-19 disease ...

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Is it time for the FDA to be independent?

3 November 2020 - Public health experts and lay observers alike have expressed concerns that, under political pressure, the FDA ...

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'Wacky' drug price system keeps costs high for patients paying for prescriptions, FDA chief says

26 February 2019 - "The sick people are helping to subsidise the healthy people. That's not how insurance is supposed to ...

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FDA speeding generic drug approvals: not just lip service

10 July 2017 - May and June 2017 have seen the most generic drug approvals since the US FDA began ...

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FDA approves two new drug treatments for diabetes mellitus

25 September 2015 - The U.S. Food and Drug Administration today approved Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin ...

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Will the FDA approve all 3 of these cancer drugs in October?

25 September 2015 - The World Health Organization identified more than 14,000 disease, disorders, and ailments in 2011, but none continues ...

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FDA approves new oral medication to treat patients with advanced colorectal cancer

22 September 2015 - The U.S. Food and Drug Administration today approved Lonsurf (a pill that combines two drugs, trifluridine and ...

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FDA approves new drug to treat schizophrenia and bipolar disorder

17 September 2015 - The U.S. Food and Drug Administration today approved Vraylar (cariprazine) capsules to treat schizophrenia and bipolar disorder ...

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FDA approves new indication for Spiriva Respimat

16 September 2015 - Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) approved Spiriva Respimat (tiotropium bromide ...

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Bristol-Myers Squibb’s Opdivo (nivolumab) receives breakthrough therapy designation from U.S. Food and Drug Administration for advanced renal cell carcinoma

16 September 2015 - Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy ...

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FDA approves Octapharma’s Nuwiq for the treatment of adults and children with haemophilia A

15 September 2015 - Octapharma USA today announced the U.S. Food and Drug Administration (FDA) has approved Nuwiq, anti-haemophilic factor (recombinant), ...

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AbbVie announces submission of a supplemental new drug application for Imbruvica (Ibrutinib) for treatment-naive chronic lymphocytic leukaemia

14 September 2015 - AbbVie, a global biopharmaceutical company, announced today that it submitted a supplemental New Drug Application (sNDA) to ...

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U.S. FDA accepts first digital medicine new drug application for Otsuka and Proteus Digital Health

10 September 2015 - Otsuka Pharmaceutical Co., Ltd. and Proteus Digital Health today announced that the United States Food and Drug ...

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