FDA - International Biopharmaceutical Industry

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Why the FDA is making a test case of a cancer drug from China

At a quick glance, the Food and Drug Administration's decision to ask its advisers for help in vetting yet another cancer immunotherapy may seem odd. After all, the ...

10 February 2022 news cancer | china

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Lilly slows FDA submission of Alzheimer’s drug after Medicare decision

Dive Brief: Eli Lilly is pushing back the timing for when it expects to finish submitting an application for U.S. approval of its experimental drug for Alzheimer's...

6 February 2022 news Alzheimer | Drug

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A biotech wins the first FDA drug approval in a rare type of eye cancer

Dive Brief: The Food and Drug Administration on Tuesday granted approval to the first drug for a rare cancer of the eye that has spread elsewhere or grown too larg...

27 January 2022 news Biotech | cancer

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Incyte withdraws cancer drug from FDA review after discussions with regulator

Dive Brief: Incyte is pulling its application for an experimental lymphoma medicine after determining that the Food and Drug Administration's requirements for conf...

27 January 2022 news cancer | Drug

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Cortexyme to shift focus after FDA places hold on experimental Alzheimer’s drug

Dive Brief: The Food and Drug Administration has ordered California biotech Cortexyme to stop testing of an experimental Alzheimer's disease drug, notifying the dr...

27 January 2022 news Alzheimer | Biotech

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FDA approves AbbVie, Pfizer drugs for eczema, creating competition for Sanofi

Dive Brief: The top-selling product for French pharmaceutical giant Sanofi now has two more competitors in the U.S. market, as the Food and Drug Administration on ...

20 January 2022 news ABBVIE | eczema

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Bluebird faces longer wait for FDA verdict on experimental gene therapies

Dive Brief: Bluebird bio will need to wait longer for a decision from the Food and Drug Administration on approval of two gene therapies it submitted last year, an...

20 January 2022 news approval | blood

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Novartis wins FDA approval for new heart drug, but faces uphill sales battle

Leqvio arrives with high sales expectations, but uptake could be slow as insurers and doctors weigh the drug's safety and cost-effectiveness. Novartis on Wednesday w...

7 January 2022 news FDA | genetic drug

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COVID-19 pills from Pfizer, Merck authorized by FDA in major pandemic milestone

Paxlovid and molnupiravir are the first oral treatments for COVID-19, potentially valuable new tools as the fast-spreading omicron variant fuels a sharp surge in case...

7 January 2022 news COVID-19 pills | FDA

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Biogen reserves four years for trial meant to confirm its Alzheimer’s drug works

A crucial study evaluating Biogen's approved drug for Alzheimer's disease is set to begin in May, the company disclosed Thursday, and if enrollment goes as expected, ...

16 December 2021 news Aduhelm | Alzheimer

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