Furore rages over FDA approval of controversial Alzheimer’s drug

17 June 2021 - Critics attack the agency’s action as reckless, but defenders say patients will benefit. ...

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The FDA is in desperate need of some soul-searching

17 June 2021 - Ordinarily, the approval of a new drug for a dreaded disease affecting millions of Americans would be ...

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COVID-19 vaccine weekly safety report (17 June 2021)

17 June 2021 - Twelve additional cases of blood clots with low blood platelets have been assessed as thrombosis with thrombocytopenia ...

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German law makers seek to ease reimbursement for advanced therapies

15 June 2021 - Advanced therapy trade group The Alliance for Regenerative Medicine has highlighted the passage of a new ...

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HHS proposes rescinding Trump era insulin, epinephrine rule

15 June 2021 - The HHS is proposing to rescind a Trump administration drug rule requiring community health centers to ...

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‘A litany of flaws’: advocacy group urges HHS to boot FDA officials over Alzheimer’s drug approval

16 June 2021 - Reacting to the controversial approval of the Biogen Alzheimer’s drug, a leading advocacy group is urging ...

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6 ways the FDA’s approval of Aduhelm does more harm than good

15 June 2021 - Like many people, I was shocked when the FDA ignored the advice of its neurological drugs ...

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Vaxzevria: EMA advises against use in people with history of capillary leak syndrome

11 June 2021 - EMA’s safety committee (PRAC) has concluded that people who have previously had capillary leak syndrome must not ...

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The FDA still lacks a permanent chief, despite pressing, weighty problems

12 June 2021 - With the pandemic easing, the federal agency’s long-term agenda for drug approvals or new issues is languishing ...

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Third member of prestigious FDA panel resigns over approval of Biogen's Alzheimer's drug

10 June 2021 - A third member of a key FDA advisory panel has resigned over the agency's controversial decision to ...

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America’s approval of an Alzheimer’s drug is premature

12 June 2021 - It may offer false hope and divert resources from more promising therapies. ...

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COVID-19 vaccine weekly safety report (10 June 2021)

10 June 2021 - Seven additional cases of blood clots with low blood platelets have been assessed as thrombosis with ...

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Two members of U.S. FDA advisory panel resign over Alzheimer's drug approval

9 June 2021 - Two members of a panel of outside advisors to the U.S. FDA have resigned in protest ...

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Proposed refinements to the regulation of personalised medical devices

7 June 2021 - Regulatory changes introducing a new framework for the regulation of personalised medical devices commenced on 25 ...

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Innovative regenerative medicine therapies – patient safety comes first

3 June 2021 - The U.S. FDA continues to facilitate the development and availability of innovative medical products, such as regenerative ...

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