3D bioprinting can help end organ transplant waitlists — if the FDA stops delaying

18 June 2021 - Right now, more than 100,000 Americans are waiting for organ transplants. Due to a lack of ...

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Let's have permanently quicker drug approvals

16 June 2021 - New drugs and vaccines likely to increase life expectancy, quality of life and save money, so we ...

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Ascendis Pharma announces extension of U.S. FDA review period for TransCon hGH (onapegsomatropin) for paediatric growth hormone deficiency

11 June 2021 - Prescription Drug User Fee Act goal date extended by three months for further review of submission to ...

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Incyte announces U.S. FDA has extended the new drug application review period for ruxolitinib cream for the treatment of atopic dermatitis

11 June 2021 - Incyte announced today that the U.S. FDA has extended the review period for the new drug ...

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Adamis provides update on Zimhi

9 June 2021 - FDA deems new drug application for Zimhi complete and establishes a target action date of 12 November ...

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Incyte announces U.S. FDA has extended the sNDA review period for ruxolitinib (Jakafi) in chronic graft versus host disease

8 June 2021 - Incyte today announced that the U.S. FDA has extended the review period for the supplemental new drug ...

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State slower to ‘adopt new drugs’ than most of western Europe

31 May 2021 - Medicines regularly not worth approving at asking price. ...

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Verrica Pharmaceuticals announces extension of FDA review period of its NDA for VP-102 for the treatment of molluscum contagiosum

28 May 2021 - Prescription Drug User Fee Act goal date extended by three months to 23 September 2021. ...

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Omeros announces extension of FDA review period for narsoplimab in HSCT-TMA

20 May 2021 - PDUFA date is 17 October 2021. ...

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CMS delays Medicare payments for breakthrough devices until December

17 May 2021 - Medicare coverage for FDA designated breakthrough medical devices will have to wait several more months, despite ...

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Long waits for life saving drugs harming Canadians: report

13 May 2021 - Canadians wait 15 months longer on average for new and potentially life-saving medications compared to Americans ...

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A 12-week sprint’: PM flags plan to vaccinate under-50s in lead-up to Christmas

19 April 2021 - More than 6 million Australians could be vaccinated in the last 12 weeks of the year ...

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Australian population unlikely to be vaccinated until end of next year

15 April 2021 - Leading public health experts have warned the Australian population is unlikely to get COVID-19 vaccinations until ...

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New blow to rollout as Novavax Covid-19 vaccine hits supply hiccup

15 April 2021 - Australia’s vaccine rollout has been dealt another blow as Novavax confirms manufacturing supply shortages mean it ...

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Adamis Pharmaceuticals provides an update on Zimhi

12 April 2021 - Adamis Pharmaceuticals today provided an update on the status of the company’s new drug application relating ...

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