FDA approves first treatment option specifically for patients with epithelioid sarcoma, a rare soft tissue cancer

23 January 2020 - Today, the U.S. Food and Drug Administration granted accelerated approval to Tazverik (tazemetostat) for the treatment of ...

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Ready for rescue – new nasally administered glucagon for severe hypoglycaemia available in Canada

23 January 2020 - Eli Lilly Canada introduces Baqsimi, another Canadian innovation to help manage diabetes complications. ...

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HLS Therapeutics files new drug submission for Perseris in Canada

23 January 2020 - If approved by Health Canada, Perseris would become the first once-monthly risperidone long-acting injectable used in the ...

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Health Canada approves Keytruda (pembrolizumab) as first-line treatment for patients with advanced renal cell carcinoma

23 January 2020 - Approval based on results of KEYNOTE-426, Where Keytruda in combination with axitinib reduced the risk of death ...

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Baudax Bio announces PDUFA date for intravenous meloxicam

22 January 2020 - Baudax Bio today announced that the U.S. FDA has set a PDUFA goal date of 20 ...

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Hunt denies helping Liberal donor push for regulator's review

23 January 2020 - Health Minister Greg Hunt has denied accusations he interfered in a regulator's decision on whether to ...

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Sick of high drug prices, insurers join hospitals to make their own generic medications

23 January 2020 - Everyone complains about high drug prices. But hospitals — and now insurers — are trying to ...

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Jazz Pharmaceuticals submits new drug application for JZP-258 for cataplexy and excessive daytime sleepiness associated with narcolepsy

22 January 2020 - Jazz Pharmaceuticals today announced the submission of a new drug application to the U.S. Food and Drug ...

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Supernus announces FDA acceptance for review of new drug application for SPN-812 for the treatment of ADHD

21 January 2020 - PN-812 (viloxazine hydrochloride), a once-daily novel serotonin norepinephrine modulating agent, demonstrates a reduction in ADHD-RS-5 total score ...

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Court of Justice upholds EMA’s approach to transparency

22 January 2020 - EMA welcomes today’s two appellate judgments by the Court of Justice that confirmed, in clear and ...

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The FDA continues to struggle with the implications of approving Sarepta’s drugs

22 January 2020 - New documents released Wednesday lay bare the stark divide within the Food and Drug Administration regarding ...

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Merck strengthens Gonal-f portfolio with approval for 150 IU pen in the European Union

22 January 2020 - New Gonal-f 150 IU pen provides additional flexibility and convenience at every stage of the patients’ stimulation ...

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FDA accepts Evoke Pharma’s NDA resubmission for Gimoti

21 January 2020 - PDUFA Target Goal Date is 19 June 2020. ...

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FDA approves first treatment for thyroid eye disease

21 January 2020 - Today, the U.S. FDA approved Tepezza (teprotumumab-trbw) for the treatment of adults with thyroid eye disease, a ...

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Old drug, new tricks: existing medicines show promise in fighting cancer

20 January 2020 - Dozens of compounds approved for other purposes can kill cancer cells selectively. ...

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