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Yearly Archives: 2020

FDA grants priority review of sutimlimab, potential first approved treatment of hemolysis

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May 14, 2020: "The U.S. FDA has granted priority review of Sanofi’s Biologics License Application (BLA) for sutimlimab for the treatment of hemolysis in...

Coronavirus (COVID-19) Update: Daily Roundup May 13, 2020

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May 13, 2020: "The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19...

Lorlatinib for previously treated ALK-positive advanced non-small-cell lung cancer

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May 13, 2020: "Lorlatinib is recommended, within its marketing authorisation, as an option for treating anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC)...

Merck Animal Health to Acquire U.S. Rights to SENTINEL®

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May 13, 2020: Merck Animal Health announced that the companies have signed a definitive agreement under which Merck Animal Health would acquire the U.S....

AbbVie completes acquisition of Allergan

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"AbbVie has wrapped up its $63 billion acquisition of the Allergan plc following receipt of regulatory approval from all government authorities required by...

WHO: People living longer and healthier lives but COVID-19 threatens to throw progress off track

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May 13, 2020: "All over the world, the COVID-19 pandemic is causing significant loss of life, disrupting livelihoods, and threatening the recent advances...

FDA Acknowledges Receipt of Bronchitol NDA Resubmission – Decision Review Date 1 November 2020

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May 13, 2020: " Pharmaceutical research company Pharmaxis Ltd announced its US licensee Chiesi Farmaceutici S.p.A. (Chiesi) has received acknowledgement of receipt of the...

Coronavirus (COVID-19) Update: Daily Roundup May 12, 2020

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May 12, 2020: "The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: The...

New data from 18 approved and investigational pfizer medicines to be showcased at asco20 virtual scientific program

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May 12, 2020: "Pfizer announced that new data from clinical trials of 18 approved and investigational medicines will be presented virtually at the...

Pfizer invites the public to listen to the webcast of Pfizer discussion at healthcare conference

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May 12, 2020: "Pfizer Inc. invites investors and the general public to listen to a webcast of a discussion with Charles Triano, Senior...

Coronavirus (COVID-19) Update: Daily Roundup May 11, 2020

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May 11, 2020: The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19...

Coronavirus (COVID-19) Update: FDA updates on surveillance inspections during COVID-19

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May 11, 2020: "During COVID-19, the U.S. Food and Drug Administration will continue to utilize and implement additional alternative inspection tools and approaches...
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